International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Antibacterial Activity of Thuja occidentalis, Thuja orientalis and Chamaecyparis obtusa
Kyoung-Sun Seo, Seong Woo Jin, Seongkyu Choi, Kyeong Won Yun

The antibacterial activity of three Cupressaceae plants (Thuja occidentalis, Thuja orientalis and Chamaecyparis obtusa) was tested against three bacteria using the agar diffusion method. The ether and ethylacetate fraction of crude methanol extract from the three plants showed potent antibacterial activity against the tested microorganisms. The result showed that Staphylococcus aureus revealed the  most sensitivity among the tested bacteria. Thuja occidentalis ether fraction and Thuja orientalis hexane fraction exhibited the highest antibacterial activity against Staphylococcus aureus. E. coli was shown the highest MIC values compared to the other two tested bacteria, which indicates the lowest  antibacterial activity against the bacterium. This study promises an interesting future for designing a potentially active antibacterial agent from the three Cupressaceae plants.

2. In Vitro Antidiabetic, Anti-Inflammatory Effects of Methanolic Extract and Isolated Compound from Andrographis paniculata (Burm. F) Wall. Ex Nees from Kemaman, Malaysia
Yahaya Najib Sani, Mainul Haque, Amirah Wan-Azemin, Khamsah Suryati, Anam Khan
Objective: This study investigated the activity of the extracts and the isolated compound on its potential in vitro antidiabetic, anti-inflammatory and potential anti-cancer effect, total flavonoid content against alpha-glucosidase enzyme inhibition and on macrophage respectively from Andrographis paniculata (Burm. F) wall. Ex Nees. Methodology: The isolation of the constituents was done using column while the in vitro anti-inflammatory and antidiabetic was done using nitric oxide and α-glucosidase enzyme inhibition assay while anticancer assessment was done performed using cell viability on various human hepatocellular carcinoma cell) and Chang liver (normal cell line) were determined by 3-(4,5-dimethylthiazolzyl-2yl)-2,5-diphenyl-tetrazolium bromide (MTT) assay. Results: Although, the total flavonoid content was low, ethyl acetate extract indicated the highest total flavonoids content and it’s statistically different from methanol, ethanol: water (1:1 v/v) and aqueous extracts. Ethyl acetate extracts exhibited the highest percentage inhibition (29.8 %) against nitric oxide scavenging activity (NaNO2) compared to other extracts. Also, the isolated crystals showed a significant inhibition against NaNO2. Moreover, the ethyl acetate extract showed the highest percentage inhibition of α-glucosidase enzyme with optimal concentration of 950μg/ml for 50 % inhibition (IC50) while the other three extracts (methanol, 50 % ethanol: water (1:1 v/v) and aqueous) indicated activity below 50 % inhibition which might be due to total flavonoid content. The potential anti-cancer effect indicates that both the methanol extract and crystals (AP02 & AP03) may have the same compound. Conclusion: The compound isolated might be Andrographolide and the activity might be due to flavonoid content for the extract.

3. Anethum graveolens: Physicochemical Properties, Medicinal Uses, Antimicrobial Effects, Antioxidant Effect, Anti-Inflammatory and Analgesic Effects: A Review
Huda Jasim Altameme,  Imad Hadi Hameed, Lena Fadhil Hamza
Anethum graveolens, belong to the family Umbelliferae, is indigenous to southern Europe. It is an annual herb growing in the Mediterranean region, central and southern Asia. Now it is cultivated widely throughout the world. It is used traditionally as a popular aromatic herb and spice that has a very long history of use going back to more than 5,000 years. It was used as a remedy for indigestion and flatulence and as milk secretion stimulant. The essential oil and different extracts of Anethum graveolens seeds exerted antimicrobial activity against wide range of microorganisms. The essential oils and acetone extracts shown antimicrobial activity against Staphylococcus aureus, Bacillus cereus, Enterococcus faecalis, Listeria monocytogenes, Escherichia coli, Yersinia enterocolitica, Salmonella choleraesuis, S. typhimurium, Shigella flexneri, Salmonella typhii, Pseudomonas aeruginosa, and Mycobacterium. Anethum graveolens seed extracts exerted moderate activity against Helicobacter pylori.

4. Endocrine Treatment of Breast Cancer: Current Perspectives, Future Directions
Tazia Irfan, Mainul Haque, Sayeeda Rahman, Russell Kabir, Nuzhat Rahman, Md. Anwarul Azim Majumder
Breast cancer remains one of the major causes of death in women, and endocrine treatment is currently one of the mainstay of treatment in patients with estrogen receptor positive breast cancer. Endocrine therapy either slows down or stops the growth of hormone-sensitive tumors by blocking the body’s capability to yield hormones or by interfering with hormone action. In this paper, we intended to review various approaches of endocrine treatments for breast cancer highlighting successes and limitations. There are three settings where endocrine treatment of breast cancer can be used: neoadjuvant, adjuvant, or metastatic. Several strategies have also been developed to treat hormone-sensitive breast cancer which include ovarian ablation, blocking estrogen production, and stopping estrogen effects. Selective estrogen-receptor modulators (SERMs) (e.g. tamoxifen and raloxifene), aromatase inhibitors (AIs) (e.g. anastrozole, letrozole and exemestane), gonadotropin-releasing hormone agonists (GnRH) (e.g. goserelin), and selective estrogen receptor downregulators (SERDs) (e.g. fulvestrant) are currently used drugs to treat breast cancer. Tamoxifen is probably the first targeted therapy widely used in breast cancer treatment which is considered to be very effective as first line endocrine treatment in previously untreated patients and also can be used after other endocrine therapy and chemotherapy. AIs inhibit the action of enzyme aromatase which ultimately decrease the production of estrogen to stimulate the growth of ER+ breast cancer cells. GnRH agonists suppress ovarian function, inducing artificial menopause in premenopausal women. Endocrine treatments are cheap, well-tolerated and have a fixed single daily dose for all ages, heights and weights of patients. Endocrine treatments are not nearly as toxic as chemotherapy and frequent hospitalization can be avoided. New drugs in preliminary trials demonstrated the potential for improvement of the efficacy of endocrine therapy including overcoming resistance. However, the overall goals for breast cancer including endocrine therapy should focus on effective control of cancer, design personalized medical therapeutic approach, increase survival time and quality of life, and improve supportive and palliative care for end-stage disease. 

5. Bioactive Compounds Investigation From Methanol Bark Extract of Pterocarpus marsupium Using GC-MS Analysis
Aruna L Hugar, Amarvani P Kanjikar, Ramesh L Londonkar
Introduction: Medicinal plants still represent untapped sources of novel compounds with potential therapeutic effects for mitigating human maladies. Pterocarpus marsupium, commonly known as Bijasal, is a well-known drug in ayurvedic system of medicine. Materials and methods: The dried bark powder of P.marsupium was extracted by Soxhlet with methanol and analyzed by gas chromatography, while the mass spectra data of the compounds found in the extract was matched with the data available at National Institute of Standards and Technology (NIST) library. Results: The results of the GC-MS analysis provide different peaks determining the presence of 10 major phytocomponents, that are 1-Penten-3-one,1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-; Geranyl isovalerate;  2-Pentadecanone,6, 10, 14-trimethyl; Cyclopropaneoctanal, 2-octyl-; Octadecanoic acid; 10-Octadecanoic acid, methyl ester; Heptadecanoic acid, 16-methyl,-methyl ester; Phytol; 4,8,12,16-Tetramethyl heptadecan-4-olide; Dasycarpidan-1-methanol, acetate with different therapeutic activities. Conclusion: The presence of these bioactive compounds justifies that the Pterocarpus marsupium can offer a base for using this compound as herbal alternative for the synthesis and development of new drug to treat various infectious diseases. However, isolation of individual phytochemical constituents might be useful to formulate a new novel drug.

6. Development and Validation of Stability Indicating Assay Method for Simultaneous Estimation of Glibenclamide and Metformin
Waje M K, Barge V U, Talole B B
A high performance reverse phase liquid chromatographic procedure is developed for simultaneous estimation of Metformin and Glibenclamide in combined tablet dosage form. The method was carried out on Agilent Hypersil ODS (4.6 x 250 mm) column with a mobile phase used consisting of Methanol: Water (0.1 % OPA) OPA= Ortho Phosphoric acid   (80:20) and the pH of buffer was adjusted to 3 using 2M Orthophosphoric acid. The detection of the combined dosage form was carried out at 228 nm and a flow rate employed was 1 ml/min and column oven temperature at 300C. The retention times of Metformin & Glibenclamide were 3.4667 & 7.3500 minutes respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification as per ICH norms. The proposed method can be used for the estimation of these combined drugs.

7. Isolation and Characterisation of Andrographolide from Andrographis paniculata (Burm. F) Wall. Ex Nees and Its Total Flavonoid Effects from Kemaman, Malaysia
Yahaya Najib Sani, Mainul Haque, Khamsah Suryati, Khairul Wan Mohd, Anam Khan
Background: Many medicinal plants have wide range of applications from food and aesthetic materials to pharmacological effect on various disease conditions. Traditionally, these plants have been used to treat many diseases including diabetes, inflammation, upper respiratory tract infections and diarrhoea either in single or combined form with other plant parts or materials. Objective: This study investigated the isolation and characterisation of andrographolide from Andrographis paniculata (Burm. f) Wall. ex Nees. Methodology: The isolation of the constituents was done using column total flavonoid conducted while the analysis was done using ultraviolet, infrared spectrum analysis (UV, IR), melting point and elemental analysis. Also, proton and carbon nuclear magnetic resonance (1H and 13C NMR) of the isolated compound was performed using different equipment. Results: Although, the total flavonoid content was low, ethyl acetate extract indicated the highest total flavonoids content and it’s statistically different from methanol, ethanol: water (1:1 v/v) and aqueous extracts. The compound obtained is colorless solid with melting point range of 228oC-238oC. This was further supported by 13C NMR spectral analysis, which displayed 20 signals for all carbon atoms and is like standard compound Andrographolide. Also, the ultraviolet analysis suggesting α, β-unsaturated lactone ring similar andrographolide while the elemental analysis shows the different elements present. Conclusion: Different extracts of A. paniculata exhibit multiple pharmacological effects. However, due to the much similarities with the isolated compound and Andrographolide the compound is suggested to be Andrographolide.

8. Development and Validation of Stability-Indicating RP-HPLC Method for the Estimation of Cuminaldehyde
Singh Rudra Pratap, Gangadharappa H V, Narke M Ramakant, Jadhav V Pooja
Cumin aldehyde is an herbaceous plant (Cuminum cyminum L.) volatile oil that used as a regular spice in kitchen foods. It also has some pharmacological properties such as analgesic, hepato-protective, anti-inflammatory, antibacterial, antimicrobial, antifungal, antiviral, antioxidant and anticancer. The key objective of the present study was to develop and validate the RP-HPLC method for the estimation of cumin aldehyde. According to the ICH guidelines, RP-HPLC stability indicating method was used in which reverse phase enable Cosmosil C18 column (250 × 4.6 mm, 5μm) used in isocratic mode. For the estimation of cumin aldehyde, sodium sulphate: acetonitrile: methanol (20:73:7 v/v) was used as a mobile phase and it was delivered at flow rate of 1.0 mL min1. The injection volume was 20 µL and elute was analyzed by a UV detector at 326 nm. Linearity was observed between the concentration range of 20 μg mL-1 -140 μg mL-1 and the correlation coefficient R2 value was found to be 0.997 ± 0.5. The method was accurate and recovery was found to be in the range of 98.06 -100.40 %. The limit of detection of cumin aldehyde was found to be 1.04 μg mL1 and limit of quantitation was found to be 3.16 μg mL1. Cumin aldehyde was subjected to stress conditions including acidic, alkaline, neutral, oxidation, and dry heat degradation. Cumin aldehyde was more sensitive to acidic, dry heat and oxidative degradation and it is stable at alkaline conditions. The method was validated according to ICH guidelines. 

9. CAPM Patient Satisfaction Survey
Marouane Nasser, M’hamed Tijane, Narjis Badrane, Rachida Soulaymani Bencheikh, Omaima  El Bouazzi
As part of the ISO 15189 certification preparation, the toxicology and pharmacology laboratory of the Poison Control and Pharmacovigilance Center of Morocco(CAPM) Satisfaction Survey for Patients Requesting Analyzes. The chosen tool was a questionnaire using 11 closed questions and 1 open. The survey was conducted on patients who performed the toxicology and pharmacology analyzes during the period January 01, 2016 to August 31, 2016. The results obtained have made it possible to evaluate the perception of the quality of the service rendered by the laboratory to these patients.

10. Development and Validation of Stability Indicating HPLC Method for the Simultaneous Estimation of Levocloperastine Fendizoate and Chlorpheniramine Maleate in Pharmaceutical Dosage Form
Sankalp Patel, Jinal Tandel, Samir Shah
The aim of the present study was to develop and validate stability indicating HPLC method for simultaneous estimation of Levocloperastine Fendizoate (LCP) and Chlorpheniramine Maleate (CPM). HPLC method for simultaneous analysis of both drugs was developed and validated according to ICH guideline. Efficient chromatographic separation was achieved on ODS column C18 (250 mm × 4.6 mm, 5 μm) using the optimized mobile phase. Stability indicating assay method was carried out by different stress degradation conditions. In HPLC method, the Retention time for LCP and CPM was 3.173 min and 5.060 min using optimized mobile phase Phosphate buffer (pH-3.5): Methanol (60:40 %v/v) and UV detection at 273 nm. The degradation of LCP, CPM and Formulation was shown to be highest in alkaline condition. Linearity was observed in concentration range of 20-80 μg/ml for LCP and 4-16 μg/ml for CPM. The correlation coefficient of LCP and CPM were respectively 0.9992 and 0.9994. All validation parameters were within the acceptable range. The LOD and LOQ values for HPLC method were found to be 0.146 μg/ml and 0.444 μg/ml for LCP and 0.0113 μg/ml and 0.0344 μg/ml for CPM respectively. The Method validation parameters showed %RSD value less than 2.

11. Novel UV Spectrophotometric Method for the Quantitative Analysis of Cefpodoxime Proxetil in Pharmaceutical Formulations by First Derivative Technique
Potdar S S, Karajgi S R, Simpi C C, Kalyane N V
The spectrophotometric method for estimation of Cefpodoxime Proxetil employed first derivative amplitude UV spectrophotometric method for analysis using methanol as solvent for the drug. Cefpodoxime Proxetil has absorbance maxima at 235nm and obeys Beer’s law in concentration range 10-50µg/ml with good linearity i.e. r2 about 0.999. The recovery studies established accuracy of the proposed method; result validated according to ICH guideline. Results were found satisfactory and reproducible. The method was successfully for evaluation of Cefpodoxime Proxetil in tablet dosage form without interference of common excipients.

12. Acorus calamus: Parts used, Insecticidal, Anti-Fungal, Antitumour and Anti-Inflammatory Activity: A Review
Shireen Sabah Kamil, Imad Hadi Hameed, Lena Fadhil Hamza
Acorus calamus is a herb used for the appetite and as an aid to the digestion. It is used for fevers, stomach cramps and cholic. Their rhizomes were used for toothache and powdered rhizome for congestion. The rhizome part is also used to treat several diseases like asthma and bronchitis and as sedative. Native tribes treated cough by making a decoction of the plant as a carminative and also for cholic. It is a main medhya drug, which has the property of improving the memory power and intellect. Acorus calamus is used in the conditions of vata and kapha, stomatopathy, hoarseness, flatulence, dyspepsia, helminthiasis, amenorrhea, dysmenorrheal, nephropathy, calculi, stragury. Acorus calamus leaves, rhizomes and its essential oil has many biological activities16 like antispasmodic, carminative and also used for treatment of epilepsy, mental ailments, chronic diarrhea, dysentery, bronchial catarrh, intermittent and tumors. It also has the insecticidal, antifungal, antibacterial, tranquilizing, antidiarrhoeal, antidyslipidemic, neuroprotective, antioxidant, anticholinesterase, spasmolytic, vascular modulator activities. The parts used in most of the experimental studies are the leaves, roots and stem of the plant. The dry rhizome contains some of the yellow aromatic oil, calamus oil that are responsible for their medicinal and insecticidal properties. Studies were also done on their rhizome part and in its oils in order to identify the active constituents and its medicinal values. 

13. The Antibacterial Activity of Gentamicin Sulphate in NaCl and Dextrose-NaCl Infusion against Escherichia coli Atcc 25922 and Staphylococcus aureus Atcc 29213
Sulistiyaningsih, Kurniawansyah I S, Anugrah S D
Gentamicin sulphate mixed into the fluid infusion of NaCl and dextrose-NaCl is the process of intravenous admixtures, where knowledge about sterility, physicochemistry and stability properties of drugs, incompatible of drugs and the risk of exposure are matter to be considered. An already reconstituted drug has a time limit of stability and the long-time mixing will decrease its activity in inhibiting bacteria. The study aims was to determined the antibacterial effect of the infusion of 0.9% NaCl and 5% dextrose-0.225% NaCl against Escherichia coli and Staphylococcus aureus, the influence of time variation of the use of gentamicin sulphate injection, and the effect of interaction of infusion and time of use towards its activity on bacteria. The laboratory experiment research method was done, which included mixing sterile preparation of gentamicin sulphate injection into NaCl and dextrose-NaCl infusion in LAF, tested antibacterial activity against Escherichia coli and Staphylococcus aureus and data analyzed with ANOVA. The results showed that the type of fluid infusion was only influential as antibacterial activity against Staphylococcus aureus but not against Escherichia coli. On the other hand, the use of time variation was effective on gentamicin sulphate activity against both bacteria. Also, the interaction of fluid infusion with time of use has no effect on its activity on bacteria.

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