International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Method Development and Validation for the Simultaneous Analysis of Duloxetine HCL and Methylcobalamine by RP-HPLC
Gouthami Thumma, Narender Boggula, Vasudha B, Anand Kumar Chettupalli
Abstract
A simple, accurate and precise method for simultaneous estimation of Methylcobalamin and Duloxetine by RP-HPLC method has been developed.  The chromatographic conditions were successfully developed by using inertsil ODS C18 5µm (4.6*250mm) column, the flow rate was 1ml/min, the mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (30:70%v/v) (pH   was   adjusted   with   orthophosphoric   acid), detection wave length was 255nm. The retention times were found to be 3.594 min and 5.328 min. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The suggested RP-HPLC method can be used for routine analysis of Methylcobalamin and Duloxetine in API and Pharmaceutical dosage form.

2. Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Pantoprazole and Cinitapride in Bulk and in Capsule Dosage Form
Gaur A, Yashwant
Abstract
A new, rapid, precise, selective and sensitive Vierodt’s/simultaneous equation method is developed for the simultaneous estimation of pantoprazole (PNT) and cinitapride (CNT) in combined dosage form. In the developed method, absorbance was measured at 289 nm (λ max of Pantoprazole) and 267.2 nm (λ max of Cinitapride). The drugs obeyed the Beer’s law in the concentration range of 13-65µg/ml and 1-5 µg/ml respectively for pantoprazole and cinitapride. Accuracy of the method was determined by recovery studies and was found to be 101.32 % and 98.9 % for Pantoprazole and Cinitapride respectively. The developed method is simple, precise, rapid and selective. It can be used for routine analysis of both drugs in bulk as well as in pharmaceutical formulations.

3. Evaluation of Auto-antibodies Levels in Miscarriages Women with Phospholipid Syndrome
Raad Ajam Sayal, Ahmed Abbas Hasan, Humam Kasem Hussein3, Murtadha M Jawad Kadhim
Abstract
Abortion is one of the most common problem in world and associated with different causes. These may be occur due to complication of microorganism infection or associated with immunological disturbance like abortion caused by Anti-phospholipid syndrome. There are many auto-antibodies produce in this syndrome like anti-phospholipid antibodies including anti-cardiolipin and anti-b2glucoprotien antibodies .In this study ,we wish to determine whether there are a relationship between the levels of these antibodies and abortion .Thirty females patients with spontaneous abortion with ages ranged between (15-45) where taken from  (Al-Hussein Medical  City/Kerbala).Control group consisted of 20 healthy people who were free from history of abortion  who matched in age and gender with patients . ACL (IgM and IgG), APL (IgM and IgG) and B2gp(IgM&IgG) EASIA Kit, Euroimmune assay) and was studied using the enzyme-linked immunosorbent assay (ELISA) method. T-test and ANOVA and Pearson correlation used to analyze results by using SPSS version 24. P-value ≤ 0.05 was considered significant. The patients with age range between 15-25 years represent high percent (73.3%).19 (63.3%) of the abortion were reported in the first trimester of pregnancy. 6 patients with ACL+&B2gP- show high prevalence than other classification. The mean value of anti-cardiolipin (26.534±3.646) show a significant results in compered to controls groups. we conclude that the Anti-cardiolipin IgG levels were increased significantly when compared to other Anti-phospholipid types.

4. Liver, Kidney Function Tests and Oxidative Damage During and after Treatment of Salmonella typhimurium Infection in Experimental Local Rabbits
Ayman Barzan Abdulgafor, Maher Saber Owain, Mustafa Salah Hasan, Mohammed Ali Hussein, Qusay Mohammed Aboud, Anmar J Al-Zobaie
Abstract
This study aimed to evaluate the liver, kidney damage caused by S. typhimurium and to estimate the oxidative damage in association with this bacteria. A highly virulent isolates of S. typhimurium were obtained from the department of internal and preventive medicine/ College of Veterinary Medicine/ University of Baghdad. A twenty five local rabbits of both genders with age range (2-4 months) weeks old were used for this study, the rabbits were divided randomly into five groups each group contains 5 rabbits :- group 1: drenched orally with 5 ml of normal saline and consider as control group, group 2: were drenched  orally with (5 ml) suspension which contain (5×109 CFU) of Salmonella typhimurium and regarded as infected group, group 3 were drenched orally with (5 ml) suspension which have (5×109 CFU) of Salmonella typhimurium then treated with a single dose of gentamicin alone at 0.05ml/kg (5mg/ml) orally after presence of signs (after 24hrs. post inoculation), group 4 were drenched (5 ml) suspension having (5×109 CFU) of Salmonella typhimurium then treated with a single dose of Ca-EDTA alone at 40mg/kg orally after presence of signs (after 24hrs. post inoculation) and group 5 were drenched (5 ml) suspension that contain (5×109 CFU) of Salmonella typhimurium then treated with a single dose of combined gentamicin at 0.05ml/kg (5mg/ml)  orally after presence of signs (after 24hrs. post inoculation) and Ca-EDTA 40mg/kg after presence of signs (after 24hrs. post inoculation). The results of biochemical profile showed a significant increase (p<0.05) in ALT, creatinine and urea levels in infected group as compared with control group, while, the treated groups especially group 5 showed a significant improvement in ALT, Urea and creatinine levels which returned to relative normal levels as compared with infected group after 96hrs. post treatment. Also, the results of oxidative stress showed a significant increase in the levels of MDA in G2, G3, G4 and G5 after 48 hrs. post treatment, while the level of GSH showed a significant decrease in the level at 48hrs., both were returned to relative normal levels after 96hrs.post treatment especially in group 5. In conclusion, S. typhimurium can causing liver and kidney damage which is manifested by increase ALT, Urea and Creatinine. Also, MDA and GSH is increased due to salmonellosis.

5. Follow-Up Evaluation on Oral Antidiabetic Drug Use: A Study of Effectiveness, Safety and Patient Adherence in Surabaya Primary Health Care
Lisa Aditama, Umi Athiyah, Wahyu Utami, Abdul Rahem
Abstract
Medication non-adherence is one of the biggest causes of leftover medicines. Up to 50% of patients worldwide do not take their prescribed medicines as recommended. Optimising the use of medication is beneficial to improving clinical outcomes for patients with chronic disease. Purpose: The aim of this study was to determine the effectiveness and safety of drug therapy, evaluate patient adherence, and identify of the patient’s non-adherence behavior for oral antidiabetic drugs (OADs). Methods: This study using non-experimental design, with mixed-methods (explanatory sequential design). A total of 32 patients with type 2 diabetes mellitus in referral program of national health care security system (BPJS Kesehatan) were included in this study from Primary Health Care in the north region of Surabaya. There are 6 domains of adherence behavior developed in this study. Results: The effectiveness of drug therapy in this study was 56,25%. About 68,75% of patients experienced to hypoglycemia and 6,25% had gastrointestinal problems caused by drug therapy.  The adherence assessment found that 43,75% patients non adherence to medication. Leftover medicines found in the patient’s home comes from multiple visits to health care facilities (53,12%) and patient non-adherence (37,5%). Conclusion: Follow-up evaluation as the continuous process in medication management services, led pharmacist in the strategic position to evaluates the patient’s response to drug therapies in terms of effectiveness, safety, adherence and also avoiding unnecessary leftover medicines.

6. Assessment of Nurses’ Knowledge about Nosocomial Infection at Burns Units in the Middle Euphrates Teaching Hospitals
Sadiq Salam H AL-Salih, Fakhria Jaber Muhbes, Nada Khazaal K Hindi
Abstract
Background: Nosocomial infections (NIs) are considered the major and common healthcare problems in most healthcare settings at most of developing countries like Iraq, important to assess the nurses’ knowledge level and identifying gaps of their knowledge about NIs. Objectives: To assess the nurses’ knowledge about nosocomial infection, and to find out the relationship between nurses’ knowledge about nosocomial infection and selected demographic variables. Methodology: A descriptive study was conducted at burns’ centers and units in the middle Euphrates teaching hospitals. The study was carried out from (25th October 2017) to (1st June 2018), A purposive (non-probability) sample was selected (129) from nurses that working at burns’ centers and units in the middle Euphrates teaching hospitals. The instrument was presented to (15) experts from several universities to be valid, the reliability of the instrument was determined through the implicated the Cronbach’s Alpha, the reliability of this instrument was (r = 0.833). Results: The result of study was showed that the majority (69.8%) of nurses had (passed score) of knowledge regarding nosocomial infection in burns’ units at middle Euphrates teaching hospitals.in addition, the present study pointed out there was a significant relationship between nurse knowledge and number of training courses about nosocomial infection. Conclusion: Nurses were pass knowledge in terms of nosocomial infections, prevention, control and precaution in patient care. Nurses age, gender, education, years of experience in-out burn unit have been not influenced their knowledge. Number of Nurses training courses have been affected their knowledge.

7. Premalignant and Malignant Changes in Symptomatic Endometrial Polyps in Women Aged 20-70 years
Susan Abed Zaidan, Alaa Abdulqader Abdulrazaq, Eaman Marouf Muhammed.
Abstract
Background: endometrial polyps are localized over growth of endometrium including glandular and stromal tissue with prominent angiogenesis regulated by growth factors. Polyps occur in different age group and could be asymptomatic and discovered incidentally or it cause abnormal premenopausal and postmenopausal bleeding. Most endometrial polyps are benign but premalignant and malignant changes also occur frequently. Objective: this study was carried out to identify the age-group in which endomaterial polyps are encountered in routine surgical pathology practice, to document the age-group in which these polyps underwent malignant changes and to identify the histological subtype of endometrial polyps according to age group. Patients and methods: This prospective study conducted to demonstrate the premalignant and malignant changes in symptomatic endometrial polyps in relation to patients age group ranging from 20-70 years with abnormal uterine bleeding examined in gynecology & obstetric department in Al-Ramadi and Al-Yarmouk Teaching Hospital during the period from January 2017 to May 2018. The endometrial samples were obtained either by D&C, hysteroscopy or the polyps were demonstrated after surgical hysterectomy. All endometrial samples were fixed in 10% formalin solution and sent to the private histopathology laboratory in Baghdad for histopathological diagnosis. Results: The total number of examined women were 150. The most common recorded age was 20-70 years. 74.6% were pre-menopausal and 25.4% of patients were post-menopausal at the time of diagnosis. Most of patients presented with symptomatic polyps in this study were in age group 41-50 years (36.6%) in which most of the polyps were benign, while premalignant and malignant changes were more common in women between 51-60 years. The final pathological diagnoses showed benign endometrial polyps (49.3%), (48.6%) were pre-malignant polyps and (2 %) were malignant polyps. From benign lesions secretary endometrium was the most common finding in 43 cases (58.1%), while simple endometrial hyperplasia without atypia was the most common finding in the pre-malignant group 40 cases (54.7%). The distribution of histopathological changes in each age group were significant with a P value equal to 0.02. Conclusion: all endometrial polyps in pre- and post-menopausal women should be removed and submitted for histopathological examination as some of them even though there are benign but could carry areas of cellular atypia or malignant transformation.

8. Effects of X-Ray Exposure on Some CMI Regulatory Cytokines in Technicians Serum Samples
Weam S Al-Hamadany
Abstract
Ionizing radiation considered as an immunosuppressive factor upon over dose of exposure. Radiation field workers usually following a periodic checkup to monitor changes in their clinical status. Cell Mediated Immunity (CMI) has an important cytokines that regulate this specific immunological process. This study estimated the Interleukins (IL-2, IL-12 and IL-18) levels in serum samples using ELISA technique. Serum samples were collected from X-ray Technicians (Radiography, Fluoroscopy and Computed Tomography Scan Technicians) working in AL-Muthanna governorate hospitals. A total of (60) technicians and (30) control were involved in this research. Results showed significant decrease in IL-2 levels and increase in IL-18 levels in test groups (technicians) as compared with controls. While, IL-12 levels did not show a difference; all obtained values were within normal range. Overdose of X-ray exposure caused CMI suppression via disturbing the levels of critical cytokines (IL-2 and IL-18) leading to CMI loss regulation.

9. The Effect of Seasonal Variation on Thyroid Hormones in Iraqi Patients
Seeham Ali Qasim, Abeer Salih Ali, Alia Essam Alubadi, Hadeel Radawi Hussein Al-Newani
Abstract
Objectives: Thyroid is an endocrine gland located below the larynx, the principal thyroid hormones are thyroxin (T4) Tri-iodothyroxine  (T3) and thyroid stimulating hormone (TSH). The present study was carried out to attain the impact of gender and seasons on the level of thyroxine (T4), (T3) and (TSH) in individuals free of thyroid disease. Methods: The changes of T3, T4 and TSH hormones in the blood serum for females and males were studied for three years (2014, 2015 and 2016). Hormonal assay was done by using VIDAS by (bio -merieuxsa). Results: The results showed that the significant increase of thyroid hormones TSH in males during winter for three years while in female the clear significantly increased in autumn for years 2014, 2015 and 2016 was shown. Then thyroid hormones in T3 and T4 in females showed height significantly increased in summer and spring for years 2015 and 2016, but the levels of T3 in males showed significantly decreased during summer, spring and winter for 2015 and 2016, and the levels of T4 decreased significantly in winter for three years studied. Conclusions: It is concluded that the gender, seasons and unstable conditions in Iraq such as anxiety especially during 2015 and 2016 have an appreciable effect on the levels T3, T4 and TSH compared with 2014 and other countries.

10. Detection of CTX-M genes from β-lactam Resistance Proteus mirabilis associated with Urinary Tract Infection in Holy Karbala province, Iraq
Barrak Thamer Shabeeb, Yasamin Khudair Alghanimi, Atheer Majid Al-Juhaishi, Muhannad Mohsen Ahmed
Abstract
A total of  325  urine samples were collected from all ages and for both sexes from patients suffering from urinary tract infections in the period from (15 February to 15 May, 2017) from Al Hussein Hospital in Karbala , The number of samples that gave a positive result for laboratory culture was 227 samples (84.69%) .The isolates were then identified according to the physiological and biochemical tests , It was found that the number of samples that were Gram negative was (59.9%) and the Proteus spp. obtained were (31.61%) of the total negative bacteria isolates. Proteus mirabilis isolates obtained from  all isolates of Proteus spp. were 38 isolates formed ratio (88.37%) ,These isolates were initially diagnosed by culture them into the MacConkey agar and blood agar followed by a number of morphological and biochemical tests. The isolates were finally diagnosed using the API 20E system. Proteus mirabilis isolates obtained from urine samples of female were 27 isolates (71.05%) and 11 isolates (28.9%) from urine samples of male. The isolates were tested for 12 different types of β-Lactam antibiotic to determine the most effective antibiotic toward these bacteria (Ampicillin, Piperacillin, Oxacillin, Cefazolin, Cephalothin , Cefoxitin , Ceftazidime , Ceftriaxone , Cefepime , Ertapenem , Imipenem and Aztreonam). The isolates of P. mirabilis showed a clear sensitivity to the  Erytapenem , Imipenem , and Aztreonam , the sensitivity ratio was 97.3% , 100% and 100% respectively. The polymerase chain reaction technique was also used to detect CTX-M gene which represents one of the three most frequent gene (TEM, SHV, CTX-M) in this bacteria The results of polymerase chain reaction showed that (17) isolates formed (44.74%) carrying the bla CTX-M gene. This study came to achieve the following objectives

11. Age of Menarche in Females of Al-Ramadi City/Iraq
Rafal  Mustafa Murshid
Abstract
Aim of the study: Estimate the age of menarche in females of Al-Ramadi city/Iraq. Methodology: This is a retrospective descriptive cross sectional study carried out in Al Ramadi city from the 1stof March to the 1st of May 2017. Data were collected from 404 secondary school girls selected randomly from different secondary schools according to the population density of Ramadi city areas. Age of menarche divided in to early menarche (8-<11 years age), normal menarche (11-14 years), and late menarche (14-16 years). Questionnaire was filled by the family and included female’s age, age of onset of her menarche, father and mother’s job, education, residency, economic, psychological status and the level of stress the family during onset of menarche. Results: The age range of the studied females was 12 to 18 years. Their mean age of menarche was 13.25 years. About 89% of the respondents were found to be within normal age of menarche, 10.3% of late menarche, and 0.5% had early menarche. The most frequent age of starting menarche was at 13 years (39.1%) followed by 14 years. Normal age menarche was found to be more prevalent among urban dwellers, females of house wife mothers, employed fathers, educated parents, living in their owned houses, and of less life stress. Conclusion: The mean age of menarche in Ramadi city was 13.25 and was higher than age recorded in Baghdad and consistent with ages recoded in many other neighboring and far countries.

12. Incidence of multiple myeloma in Iraqi people
Farhan A Risan
Abstract
Multiple myeloma patients were carried out the period (October/2017-February/2018), for measurement the concentrations of IgM,IgM&IgG antibodies,types of light chains(kappa&Lambda) alpha-1,2 and gamma as well as albumin & protein levels in the sera of 47 (25 males & 22 females) patients compared with 29  healthy humans as control group. The diagnosis of patients were done by immunofixation technique.The positive titer of immunoglobulins showed 2(2.6%) IgM ,6(7.6%) IgA &33(43.4%) IgG, while 6(7.8%) was negative titer. The light chains Kappa 22(28.9%), Lambda 20(26.3%), while 5(6.6%) negative, it was noticeable changes among patients and healthy group. The alpha-1 in patients 19(25%), alpha-2 14(18.5%), beta 9 (11.8%), gamma 37(48.7%) were abnormal in patients of multiple myeloma (observed changes). Abnormal concentration of albumin and protein in the multiple myeloma patients showed 28(36.8%),18(23.6%) respectively also highly observed changes within patients and healthy group

13. Sidrophore Production and Phosphate Solubilization by Bacillus cereus and Pseudomonas fluorescens Isolated from Iraqi Soils and Soil Characterization
Zaid Raad Abbas, Aqeel Mohammed Majeed Al-Ezee, Sawsan H
Abstract
This study was conducted to explore the ability of Pseudomonas fluorescens & Bacillus cereus to solubilizing a phosphate in soil for enhancing the planting growth &, its relation with soill characterization. The isolates were identified as P.fluorescens and B. cereus using convential analysis and, its phosphate solubilization ability and sidrophore was shown by the clear zone formation on National Botanical Research Institute’s Phosphate medium. Moreover, Pseudomonas fluorescens isolates (n = 9) and three of B. cereus isolated from agricultural area in Baghdad university, Mustansiriyah university and Diyala bridge. Results displayed that bacterial count were varied in soil samples according to their region, and ranging from 30 to 60 *10 2 CFU/g in Baghdad university soil to 10—20 *10 2 CFU/g in Mustansiriyah university soil, the Baghdad soil macronutrient which included: NH4, NO3, P, and K were, 8.42, 20.53, 19.09, 218.73 respectively, While the physio analysis revealed that the mean of pH was 7.3 and EC was 8.63. on the other hand the micronutrient analysis indicated that the soil samples were included Ca, Fe, Mn, Zn and Cu which gave their mean 5025.9, 8.9, 4.9, 0.5   and 1.5 respectevily. Results revealed that all isolated bacteria (9 isolates of P.fluorescens  and three isolates of B. cereus gave ahalo zone which mean their ability to be phosphate solubilizing bacteria at 100%. Results revealed that all isolated bacteria were detected a ability to produce high levels from chelating agents (siderophores)) by P.fluorescens  &. B cereus at 100%, when appeared ahalo clear zone. Furthermore, the high levels of phosphate solubilization and siderophore production were grouped in bacterial species isolated from Iraqi soils. might be attributed to many soil factors such as soil nutrient status, soil acidity, water content, organic matter and soil enzyme activities.

14. Study the Level of Certain Biochemical Parameters in Iraqi Patients with Thyroid Disorder
Shatha H Jwaid, Ahmed G Sabbar, Amani M Touma
Abstract
Aim: This study aimed to evaluate changes in serum levels of some elements (phosphorus   and chloride ions) and relationship with hypothyroidism, hyperthyroidism; and euthyroidism as a control groups. Method: Analysis of serum phosphorus and chloride were done by enzymatic methods using AGAPPE kit. Result: Patients with hyperthyroidism and hypothyroidism showed highly significant increase in serum phosphorus levels (p<0.001). In case of hypo- and hyperthyroidism significant difference could not be obtained among euthyroidism and patients (p>0.05) in chloride level. While a positive correlation with thyroid stimulating hormone (TSH), serum phosphorous and chloride in case of hypothyroidism.  In hyperthyroid patients, the correlation was negative for phosphorous and positive for chloride, also none of correlations were statistically significant (p>0.05).  Conclusion: Thyroid patients should be regularly checked for serum electrolytes. Early discovery and management can prevent the further complications and will be useful during the controlling of thyroid patients.

15. Knowledge and Attitudes About the Human Papilloma Virus and Cervical Cancer Among A Sample of Paramedical Students in Baghdad Teaching Hospital
Atta Ah Mousa Al-Sarray
Abstract
Objective : to determine the level of knowledge and attitude about the human papillomavirus and cervical cancer among asample of paramedical students in Baghdad teaching hospital. Methods: Across –sectional study was carried out for a period of seven month stating on 1st of August 2017to 30 Decmber 2017. Results:.   Mean age of study sample 20±9 higher percentage in the age groups 20-29 and lower percentage  in the age groups (<20), most cases were females 52.96% & from urban area74.67%  regarding level of education 34.21% from  college of health &medical technologies ,28.95%  College of  Nursing,22.37% Baghdad medical institute&14.47% from Al-mansour medical institute. Overall knowledge score , higher percentage of study sample (63%) had fair score of knowledge regarding Human Papilloma Virus & age had no influence on knowledge score, Males had better knowledge the females students & nursing &Baghdad institute students displayed better knowledge compared to other students & urban residence students  display better knowledge score  about HPV the association between knowledge score and gender and level of education & residence was found to be statistically significant . Regarding attitude  higher percentage of study sample more than 90% agree with the question (Having only one sex partner decreases the risk of acquiring HPV infection) &more than 80% agree with  preventive measures such as Education on HPV & cervical cancer better started at primary school.& Condom prevents HPV virus equally as it prevents HIV transmission while( 54.93%) of study sample agree with the question Pap smear test is a screening test to detect cervical cancer . (46.38%) of study sample agree with HPV vaccine can prevent the development of genital warts & cervical cancer. While  ( 44.40 % ) of study sample agree with  HPV vaccine is delivered in a series of 3 shots injection over 6 month schedule. Higher percentage (49.01%) of study sample had good attitude score while lower percentage 13.82% had poor score. Conclusion: The findings of this study conclude that the level of knowledge of paramedical student was fairly lacking; Males had better knowledge the females students & nursing &Baghdad institute students displayed better knowledge compared to other students, urban residence students display better knowledge score about HPV overall, their attitude score is good about the severity of cer­vical cancer and the benefit of HPV vaccina­tion. Recommendation: Health education measures about mode of transmission, symptom, complication and methods of prevention especially vaccination program.

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