Advancements to be made in product, process, or quality management system are through the corrective and preventive actions (CAPA) method only, to eradicate non-conformities and other undesirable circumstances. CAPA is a regulatory concept that focuses on systemic investigations to determine the root cause and explain and resolve problems while seeking to avoid their re-occurrence. Regulatory inspections offer greater importance for CAPA, and for this reason, they will highlight the systems followed in the organization and the technical skills of the people involved in different activities. During the investigation, there is a mechanism to ensure that the nonconformities are monitored and that corrective steps are taken to ensure the product’s quality. Identify the issue and consider its effect on the company’s products and prestige. To investigate the possible cause and arrive at the root cause to investigate systematically.

Two approaches to develop an analytical method are “one factor a time (OFAT)” and “analytical quality by design (AQbD)”. In OFAT approach, only one parameter can be optimized at a time this have chances of method failure. Our aims is to give insight to the analytical method development and validation by AQbD approach. The present review discusses usefulness of AQbD tools in the high performance liquid chromatography (HPLC) method development, method optimization and validation. HPLC method development by using AQbD tools involves establishment of general analytical target profile (ATP) for analytical procedure, selection of critical quality attributes and risk assessment of the developed chromatographic method. This review gives information of various parameters of method validation like specificity, linearity, accuracy, precision, limit of detection (LoD), and limit of quantitation (LoQ), robustness and sensitivity as per International Council for Harmonization (ICH), United States Pharmacopoeia (USP) guidelines, and Food and Drug Administration (FDA).

This work was conducted to study the blue dye removal from textile company wastewater by the adsorption process using a continuous system (hydrogel composite). The process of preparing Graphene Oxide/Poly (acrylic amide/Formic acid) GO/P(AM-FA) hydrogel surface depends on the principle of swelling hydrogel behavior and pH-dependent, which in turn becomes a high possibility for the surface swelling of the hydrogel to remove the Indigo Carmine dye very quickly from the aqueous solution. Several techniques were used to determine the properties of the prepared surface before and after the adsorption process, including X-ray diffraction (XRD), thermogravimetric analysis (TGA)). Several factors affecting the adsorption process were studied, including (equilibrium time, pH effect, surface weight effect, ionic strength effect, and temperature effect). It was found that the best equilibrium time was after one hr. When studying the Effect of weight, it was found that with increasing weight, the percentage of removal increased and the efficiency of adsorption decreased, where the best weight was 0.05 g. The thermodynamic factor was studied, and it was found that the enthalpy value is negative, and through the negative value of Gibbs free energy, it was found that the reaction is spontaneous.

This article aims to provide a simple, precise, accurate, and sensitive UV spectrophotometric method to analyze azithromycin dihydrate formulations. Azithromycin dihydrate is a semisynthetic azalide subclass of macrolides antibiotic used to treat various bacterial infections. This method emphasizes the chemistry of azalide that azithromycin undergoes a hydrolytic reaction at glycosidic bond when reacted with concentrated sulphuric acid to produce yellow aglycone solution exhibiting absorbance maximum at 480 nm. Experimental conditions for the analytical method were optimized and validated. The calibration curve was linear in the range of 20 to 60 μg/mL with R² = 0.9994 with limit of detection (LoD), and limit of quantitation (LoQ) of 1.936 and 5.868 μg/mL, respectively. The developed analytical method met the ICH Q2 (R1) criteria and was successfully applied to azithromycin mucoadhesive buccal tablet, which showed no interference with the excipients.

In this work, graphene oxide/poly (acrylic acid-co-malic acid) (GO/P(AA-co-MA)) composite as adsorbents for Rhodamine B dye in aqueous solutions were studied with kinetic adsorptions. The adsorption method was used to remove dye from aqueous solutions using a high-efficiency surface that can swell and retain its pollutant inside, where the polymer was prepared poly (AA-co-MA). Then graphene oxide was loaded (GO/P(AA-co-MA)) to increase the surface efficiency and swelling process. Several important techniques were measured for the prepared polymer (p(AA-co-MA)) and surface (GO/P(AA-co-MA)) for the x-Ray diffraction analysis (XRD), atomic force microscopy (AFM), and thermal gravimetric analysis (TGA). Several experiments were conducted to estimate the optimum conditions of adsorption, the most important of which is the equilibrium time, where the best equilibrium time was (60 min) and the effect of surface weight the best (0.05 g) that give the maximum adsorption efficiency (35.5 mg/g). Study three isotherm, Langmuir, Freundlich and Timken isotherms, was found to conform to the Freundlich isotherm depending on the value of (R2 = 0.9494). Also, study adsorption kinetics. First order and the second order was found to obey the second-order kinetics depending on the value of (R2 = 1) compared to the first-order kinetics the value of (R2 = 0.6821).

A simple, economical, precise, and selective reverse gradient phase high-performance liquid chromatography (RP-HPLC) method has been validated and developed to estimate related impurities of metformin and teneligliptin in a combined tablet dosage form. A RP-HPLC analysis was performed on Hypersil BDS C18 column, and its size was 250 mm X 4.6 mm, 5 μm with using mobile phase Acetonitrile and 0.05M potassium dihydrogen Phosphate with buffer pH-4.0 in the ratio of (20:80) at 225 nm detection wavelength with the flow rate of 1.0 mL/min. The analytical method was validated according to International Council for Harmonization (ICH) guidelines. The linearity was observed in the Limit of Quantitation (LoQ)-37.5μg/ml range for Metformin and its related impurity A. Similarly, the LoQ-1.5 μg/mL range was observed linearity for Teneligliptin and its related impurity B. The correlation coefficient was more than 0.990 for both metformin and its related impurity A and teneligliptin and its related impurity B. The %recovery value was found to be a minimum of 96.181% and a maximum of 102.816% for metformin Impurity A. Similarly, the %recovery value was found to be a minimum of 96.999% and a maximum of 103.824% for teneligliptin impurity B. The relative standard deviation value for repeatability, interday precision, and intraday precision was less than 5%. The Limit of Detection (LoD) value was found to be 0.940 μg/mL for Metformin and 0.206 μg/mL for its related impurity A. The LoD value was found 0.038 μg/mL for Teneligliptin and 0.009 μg/mL for its related impurity B. The LoQ value was found at 2.849 μg/mL for Metformin and 0.623 μg/mL for its related impurity A. The LoQ value was found 0.116 μg/mL for Teneligliptin and 0.026 μg/mL for its related impurity B. The proposed method was found to be specific, linear, sensitive, precise, accurate, and robust in nature.

Adsorption experiments were carried out at temperature (25°C) to remove the methyl violet (MV) dye using the hydrogel as an inexpensive, more effective surface. We studied two kinds of adsorption isotherms i.e., Freundlich and Langmuir models depending upon the linear and non-linear methods. The results depending on the non-linear is the best way to obtain isothermal parameters compared to the linear method. Comparing the Freundlich model with the model Langmuir in the linear and non-linear method, the Freundlich model is the best., where the value of the linear method (R²= 0.8796) or the non-linear method (R²=0.9887).

Petroleum and petrochemical pollution, such as petroleum hydrocarbons (PHCs), is one of the most important environmental threats today due to its global dispersion. Contamination by these chemicals degrades the global environment and reduces biodiversity significantly. So that Pseudomonas fluorescence, Pseudomonas aeruginosa, and Pseudomonas putida isolated from contaminated soils with hydrocarbons could produce laccase with higher productivity by P. putida. SSF conditions with rice bran were better than with wheat bran in the induction of laccase production. The degradation of hydrocarbons with purified laccase increased with time and the maximum degradation level was appeared after 12 days then declined at the peak with time, therefore; the potential employment of microbes as biological instruments might provide a more cost-effective and efficient way to reduce waste and save natural resources, could be a viable answer to one of modern society’s most pressing issues.

The spread of healthcare-associated illnesses (HCAIs) is aided by microbial contamination of the hospital environment. Bacterial contamination, bacterial profiles, and antibiotic susceptibility patterns of bacterial isolates from ambient surfaces and medical equipment were investigated in this study. At Al-Hilla, a general teaching hospital in Babylon, Iraq, cross-sectional research was done. The operating room theater (ORT), the intensive care unit (ICU), and the material and sterilizing center all have a total of 120 inanimate surfaces (MSC). Routine bacterial culture, gram staining, and a battery of biochemical testing were used to identify all isolates. The Kirby–Bauer disk diffusion technique was used to establish antibiogram profiles for each detected bacterium, according to the Clinical and Laboratory Standards Institute’s criteria (CLS). The study’s findings revealed that 120 bacterial isolates had favorable bacterial microscopy results. The isolates came from six different species, four of which were Gram-negative and two of which were Gram-positive. When tested for antibiotic susceptibility, all bacterial isolates were found to be MDR bacteria.

An ultra-sensitive spectrofluorimetric work is developed for Mycophenolate mofetil, an immunosuppressant drug using Shimadzu RFPC-5301 Spectrofluorimeter, Shimadzu, Japan, equipped with 150W Xenon arc lamp, assisted by RFPC software. The excitation and emission wavelengths for Mycophenolate mofetil were found to be 350 nm and 438 nm respectively. A linear relationship was in the concentration range of 0.1–1.0 μg/mL for Mycophenolate mofetil. The assay results obtained for the marketed formulation were 102.5% for MMF. The method was validated for different parameters as per the International Conference for Harmonization Guidelines.

The lectins produced by Lactobacillus acidophilus and Lactobacillus plantarum have a wide range of abilities to hemagglutinate human erythrocytes, with more significant titers of hemagglutination blood group type O+ and lower titers of hemagglutination blood group type A+ and B|+. Also, L. acidophilus produced lectin with a higher titer than L. plantarum. It is extracted by glass beads and precipitated by acetone solvent. Six Candida albicans isolates were isolated from oral candidiasis. The highest antifungal activity of extracted lectin was against the tested Candida albicans isolates in a dose-dependent manner so that the lectin has promised an alternative to overcome multiple antifungal resistance.

Flavonoids were extracted from the peels of the Orange (Citrus sinensis L.) plant. The total flavonoids were detected with qualitative and quantitative assays using two solvents, n-hexane and methanol, then purified by silica gel chromatography. Varying bacterial genera from urinary tract infection (UTI) infections were tested for biofilm development. It was discovered that these isolates had different biofilm potential. The use of flavonoids led to reducing biofilm formation in a dose-dependent way so that Pseudomonas aeruginosa had the highest inhibitory activity at 70%, followed by Klebsiella pneumoniae at 68 % and Candida albicans at 65%. In contrast, Escherichia coli and Staphylococcus aureus showed lower inhibition rates of 33 and 34%, respectively. These findings suggest that flavonoids may effectively treat biofilm-associated bacterial infections and overcome multi-antibiotic resistance challenges.

Adsorption plays an effective role in pollution control, water treatment, and reuse. In this study, the removal of Streptomycin drug from aqueous solution was adopted by preparing a hydrogel surface for drug absorbent. The poly (PVA-AAM) hydrogel surface was prepared by relying on the polymerization of free radicals, using KPS as a starting material for free radicals, and using the cross-linking agent (AMB). The surface was studied and characterized by using several techniques such as (FTIR, TEM, AFM, and BET). Several important factors were studied, including (the effect of equilibrium time, the ionic strength, and the effect of temperature). The adsorption efficiency decrease when the concentration of salt increase, and the best weight (0.05 g) give higher adsorption capacity and best pH in the acidic medium. The study showed that adsorption efficiency increases with decreasing temperature through the adsorption process at different temperatures. The change in the values of thermodynamic functions (Entropy, Enthalpy, and Gibbs free energy) was calculated and found the reaction spontaneous and exothermic process. The adsorption isotherms were studied through the results, and it was found that it obeys the Freindlich model

An accurate, precise, and rapid reverse-phase high-performance liquid chromatographic (RP-HPLC) method is developed and validated to estimate Denaverine HCl in bulk and injection dosage form is used in the treatment of antispasmodic drugs in Veterinary medicine. This method is based on the drug separation in reversed-phase mode using Symmetry C18 Column (4.6 x 150 mm, 5 μm, Make : XTerra) The optimized mobile phase was disodium hydrogen phosphate buffer (pH 3.5): Acetonitrile (30:70 %v/v). The flow rate was 0.6 mL/min and UV detection was 306 nm. The retention time was 3.2 min for Denaverine HCl. Under ICH guidelines validation, it was accurate and reproducible. Linearity was in the concentration range of 10–50 μg/mL for Denaverine HCl. The mean percent recovery of samples at each level for both drugs was 101.3 %v/v for denaverine HCl. It may be used for quality control of bulk and injectable pharmaceutical dosage forms.

A descriptive cross-sectional study was conducted at maternity hospitals in Baghdad among pregnancies with gestational diabetes to identify gestational diabetes among those who attend the Maternity Hospitals in Baghdad city. A purposive sample of 140 pregnant women was selected from maternity Hospitals in Baghdad city. The description of the demographic characteristics of study groups includes the following variables (age of pregnant, stage of pregnancy, history of diabetes during pregnancy, history of diabetes before pregnancy, history of abortion, time of abortion, family history of DM, history of another disease. Data were obtained from pregnant women through the utilization of the study instrument, an interview technique for each woman, and a review of their medical records as means of data collection. Tables and graphs were used to analyze and assess the results of the study under the application of the statistical package (SPSS) version 20.0. Most of the 32.9% were in the age group>35 years old. A 42.9% of cases were in the 3rd stage of the trimester. Most of them had a history of diabetes during pregnancy. Half of them had a history of diabetes before pregnancy. Half of them were taking the medicine for GD and the majority of them had a history of diabetes. A total of 40% of them had a history of another disease. We recommended emphasizing the need for implementing and enforcing the new diagnostic values.

Fourteen Staphylococcus epidermidis isolates were isolated from twenty-two skin samples collected from healthy persons. Some S. epidermidis isolates produced the bacteriocin by using S. aureus and Pseudomonas aeruginosa as indicator strains. A total of 30% acetone was applied to extract bacteriocin from S. epidermidis. Bacteriocin demonstrated strong bactericidal activity against all uropathogenic strains tested with values of minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) between 8 and 128 μg/mL, while for ciprofloxacin, MIC and MBC levels ranged from 64 to 2056 μg/mL. The synergistic activity for bacteriocin with ciprofloxacin enhanced ciprofloxacin activity to high levels with P. aeruginosa, Klebsiella pneumonia, and Escherichia coli. These findings suggest that bacteriocin could effectively treat uropathogenic infections to help overcome the challenges of multi-antibiotic resistance.

Background: Staphylococcus sp. is the most dominant human pathogen, responsible for a variety of chronic and severe infections. There is mounting evidence that persisters are associated with treatment failure and relapse of persistent infections. While some essential oils were reported to have antimicrobial activity against growing Staphylococcus sp., the activity of essential oils against Staphylococcus sp. enriched in persisters has not been investigated.  Materials and Methods: In this study, we collected 100 isolates of Staphylococcus sp. from the oral cavity of patient infections that are fully characterized & identified by standard bacteriological procedures, using a biochemical test and VITEK2 system compact. Susceptibility tests for different antibiotics are used to evaluate the medical device reporting (MDR) of S. aureus and S. epidermidis and evaluate the anti-bacterial properties of essential oil to the same MDR under study. Different concentrations of essential oil from a source like medical plants and herbs are used as anti-bacterial.  Results: These essential oils expressed antimicrobial activity against clinical isolates of MDR S. aureus and S. epidermidis compared with antibiotics.  Conclusion: It is highly recommended to use EOs as an economical alternative anti-bacterial agent, especially with materials that make toothpaste and mouthwash, because of their effective ability to inhibit bacterial growth.

The work deals with one of the applications of adsorption from solution. It deals with the study of the removal of Indigo Carmine dye on the selected eco-friendly surface (Graphene Oxide/poly (acrylic amide / Formic acid)). This research relied on preparing a GO/P(AM-FA) hydrogel surface that can be prepared from available and inexpensive materials with high efficiency in removing the Indigo Carmine dye from its aqueous solution. The physical and chemical properties of the surface were studied through several important techniques, including (fourier transform infrared (FTIR), field emission scanning electron microscopy (FESEM), and transmission electron microscopy (TEM)). Two types of Langmuir and Freundlich adsorption isotherms were studied and through the results. It was found that it obeys the Freundlich model depending on the value of (R2 = 0.9276) for heterogeneous surfaces. Also, the adsorption kinetics of first order and second order were studied, and the results found that it obeys the second-order depending on the value of (R2 = 0.9999).

HPLC and Spectrophotometric methods are developed to estimate Quercetin in Calendula extract. Developed methods were statistically evaluated according to ICH guidelines. Retention time of Quercetin was found to be 12.06 min and absorption maxima comes out to be 374 nm. Quercetin content in calendula extract was calculated to be 0.190 mg/mL by UV spectrophotometric method. Accuracy data was found to be within the range which shows good recovery values for both methods. Sensitivity data gave limit of detection (LoD) 0.014 μg/mL and limit of quantitation (LoQ) 0.0043 μg/mL for high performance liquid chromatography (HPLC) and LoD 0.82 μg/mL and LoQ 2.47 μg/mL for UV spectrophotometric method. No specific changes in parameters were found showing the method robust and rugged. The repeatability, Inter-day and Intra-day precision of Quercetin gave RSD below 2% showing proposed method is highly precise. Validation parameters for HPLC and UV spectrophotometric method of Quercetin were determined with no mutual significant variance.

Hydrogel can be swelling in water and is three-dimensional polymeric. Because of its ability to absorb water in large quantities, it is highly efficient in removing pollutants. The hydrogel was prepared from low-cost and available materials, and the hydrogel surface has high efficiency for removing chloramphenicol (CAP) from an aqueous solution. Many of the chemical and physical properties of the prepared surface were studied from these important techniques (fourier transform infrared spectroscopy (FTIR), x-ray diffraction analysis (XRD), transmission electron microscopy (TEM), and acute flaccid myelitis (AFM)). The adsorption capacity increased between 1-minute and 25 minutes, after which the equilibrium time for the hydrogel surface reached the equilibrium state after one hour. adsorption method is perfectly appropriate for model second-order, giving the best value of (R2=1) and the K2 constant of rate (0.1414 g.mg^-1min^-1 )the temperature adsorption (25^oC).

Gliclazide was estimated in human plasma using a very sensitive and fast liquid chromatography method coupled to mass spectroscopy (LC-MS), where glipizide was used as an internal standard (IS). Samples were prepared using the liquid-liquid extraction method and analyzed by employing a C18 column with a mobile system composed of methanol (90): water (10): formic acid (0.1) (v/v/v). Gliclazide was chromatographed and analyzed by MS detector equipped with electro-spray ionization (ESI) method under positive ion mode with multiple reactions monitoring (MRM) for recording the transition for gliclazide (m/z parent ion 324.1 and daughter ion 127.2) and IS (m/z for parent ion 446.2 and daughter ion 321.1). In this linear method (20-9125 ng/mL), the minimum quantifiable value was 20.1 ng/mL. The recovery of the extraction process for gliclazide was 100.5% and for glipizide (internal standard) was 102.5 % from a biological matrix. The validation of the method was done as per USFDA regulatory guidelines so that this method can be used to precisely evaluate pharmacokinetic parameters in the regulated bioequivalence studies.

Cancer is the main cause of death in economically developed countries and the second cause of death in developing countries. The main objective of this study is to develop and compare the In vitro release properties of conventional and PEGylated capecitabine liposomes for the treatment of colon cancer. The film hydration method was used for the preparation of conventional and PEGylated capecitabine encapsulated liposomes. The film hydration method was used for the preparation of conventional and PEGylated capecitabine encapsulated liposomes. The formulation for the release of capecitabine liposomes was optimized and examined by the dialysis method. In vitro drug release studies showed a significant difference in the percentage of the cumulative drug release pattern. The pegylated liposomes showed prolonged release due to the presence of a PEG coating on the surface, which slowly releases the active ingredient over an extended period of time. SL3-CAP formulations showed a longer release over 36 hours and gave a release of 95 ± 0.3% of the drug compared to the conventional liposomal formulation with 81.% for 24 hours. The drug release from conventional liposomes followed zero order kinetics, and Korsmeyerpeppas and stealth liposomes followed the Higuchi pattern with an n-value greater than 1, indicating a diffusion of the super case II type when compared to conventional liposomes.

The genus Tanacetum belongs to the family compositae or asteraceae. The literature review sheds light on medicinal, herbicidal and disinfectant properties of Tanacetum species of flowering plants through effective isolation of ecologically significant essential oils. Species of Tanacetum have been used as therapies in traditional medicine since early times throughout the world. Hydro distillation and the microwave-assisted process have been utilized to isolate volatile oils, ethyl esters and other derivatives from herbaceous plants of Tanacetum. The literature review of phytochemical studies on different Tanacetum species revealed many chemical constituents. Tanacetum species have traditionally been used to manufacture cosmetics, dyes, preservatives, insecticides, medicines, and herbal remedies. Attention is increasing in species of Tanacetum due to its essential oils, bioactive compounds like the presence of sesquiterpene lactones, and bitter substances, which have been exhibited in biological activities like growth-regulating, cytotoxicity, anti-microbial activity, anti-viral activity, and anti-cancer activity etc. This also discusses the impact of fluctuating environmental conditions, especially greenhouse conditions, on concentrations of potent secondary metabolites like parthenolide and flavonoid derivate. The genus is grown extensively in many parts of the globe. Its importance as a medicinal plant is expanding rapidly, with more robust findings confirming its wide range of medicinal applications.

Tapentadol is a hydrochloride of 3-[(1R,2R)-3-(dimethyl amino)-1-ethyl-2-methylpro-pyl] phenol. Tapentadol being an artificial new painkiller that operates as an opioid receptor agonist and a noradrenaline re-uptake inhibitor in the central nervous system. Tapentadol glucuronide conjugate is a significant breakdown product expelled in urine, and unsettled stomach and nausea are common side effects. This review article explains the estimation of tapentadol and related compounds using instruments such as UV-visible spectrophotometer, capillary electrophoresis, high-performance thin-layer chromatography (HPTLC), high performance liquid chromatography (HPLC), liquid chromatography with tandem mass spectrometry (LC-MS-MS), ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). In addition, this review summarizes tapentadol’s pharmacodynamics, pharmacokinetics, and drug interactions.

Cancer is one of the critical public health challenges in the world. All cancer therapies have been used without the best choice due to these therapies being limited in activities with many side effects representing new problems. With time researchers have tried to find an advanced strategy for more activity with less toxicity and fewer side effects. Nanomaterials witness very large success as drags for many diseases and hold a promising future in complex, incurable diseases such as cancer. Bio-synthesized or what we name green chemistry of metallic nanoparticles, which shown promising results, encourage cancer use before using as drug delivery systems. This review highlights an overview of the materials that could be used as reduction reagents to synthesize AgNPs and bimetalic Ag: AuNPs and Ag: PtNPs by using them as nano-therapeutics for cancer with less side effect.