International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1.Diagnostic Performance of AFP, Autotoxin and Collagen IV and Their Combinations for Non-invasive Assessment of Hepatic Fibrosis Staging in Liver Fibrosis Patients Associated with Chronic HCV
Entsar A. Saad, Salem A. Habib, Mona S. Eltabeey
Background: Lately, several studies have utilized non-invasive serological markers to assess liver fibrosis and some are currently being validated as potential tools to determine liver damage. Purpose: Our aim was to investigate the diagnostic performance of AFP, autotoxin and collagen IV as non-invasive biomarkers of hepatic fibrosis. Patients and methods: 45 males and 15 females with chronic hepatitis C were enrolled in the current study. Laboratory assessment was done for all subjects in form of complete blood picture, liver function test, alpha fetoprotein (AFP), collagen IV and autotaxin. Patients were grouped according to the stage of fibrosis into F1, F2 and F3. Results: Mean serum values of AFP, autotaxin and collagen IV were elevated in all patients compared to healthy controls. Surprisingly, with increasing fibrosis stage AFP showed non-significant change while collagen IV and autotoxin showed significant increase (P<0.01 and P<0.0001, respectively). Autotaxin and collagen IV were significantly (P<0.01 and P<0.05, respectively) lower in F1 patients than those with F2-F3 but AFP level showed non-significant change. Autotaxin had the highest area under ROC curve and the highest accuracy for discrimination of F1 from F2-F3 patients and for discrimination of patients with F3 from F1-F2. Different combinations between AFP, collagen IV and autotoxin showed improvement in the accuracy. Conclusion: It was concluded that serum autotaxin may at least serve as a new clinical non-invasive alternative in patients who are not candidates for liver biopsy for diagnosis of liver damage. Autotaxin combination with collagen IV and AFP addition make them more useful.

2. Analysis of Bioactive Compounds of Methanolic Leaves extract of Mentha pulegium Using Gas Chromatography-Mass Spectrometry (GC-MS) Technique
Israa Adnan Ibraheam, Mohammed Yahya Hadi, Imad Hadi Hameed
The objective of this study was analysis of the secondary metabolite products. Bioactives are chemical compounds often referred to as secondary metabolites. Sixteenth bioactive compounds were identified in the methanolic extract of Mentha pulegium. The identification of bioactive chemical compounds is based on the peak area, retention time molecular weight and molecular formula. GC-MS analysis of Mentha pulegium revealed the existence of the Erythritol , Cyclohexanone , 3-methyl-,(R)- , 2,4-Dihydroxy-2,5-dimethyl-3(2H)-furan-3-one , 1-Oxaspiro[2.5]octan-4-one ,2,2,6-trimethyl-, cis- , Terpinyl formate , Acetamide , N-methyl-N-[4-(3-hydroxypyrrolidinyl)-2-butynyl]- , Pulegone , 2-Oxabicyclo[3.3.0]oct-7-en-3-one , 7-(1-hydroxypentyl)- , 2(3H)-Naphthalenone ,4,4a,5,6,7,8-hexahydro-1-methoxy- , 2-Cyclopenten-1-one , 2-(2-butenyl)-4-hydroxy-3-methyl-,(Z)- , (5β)Pregnane-3,20β-diol  14α,18α-[4-methyl-3-oxo-(1-oxa-4- , 2-(4-(But-2-yl)phenyl) propnoic acid , Nootkaton-11,12-epoxide , 2-Heptanone , 6-methyl-6-[3-methyl-3-(1-methylethenyl)-1-cyclo , Cholestan-3-ol , 2-methylene-, (3β,5α)- , 1-Heptatriacotanol and Digitoxin.

3. Identification of Flavonoid Glycosides of Methanol Extract from Cucumis dipsaceus Ehrenb. (Fruit) by using HPLC-UV-ESI-MS Methods
Suman Lata, Sanjiv Kumar Mittal
The present work is to identify the Chemical Composition of methanolic extract from Cucumis dipsaceus Ehrenb. (Fruit) by using HPLC-UV-ESI-MS Methods. It is very proficient method with amalgamation of liquid chromatography attached to electrospray ionization mass spectrometry in tendem means with positive and negative ion recognition. This is a simple and rapid method for characterization of flavonoid glycosides by using Reversed Phase High Performance Liquid Chromatography coupled to Electrospray Ionization Quadropole Time – of – Flight Mass Spectrometry (RP-HPLC-ESI-Q-TOF-MS). The correctness of mass information generated by Q-TOF-MS jointly with the fragmentation blueprint of the complete scan sprint of MS/MS investigation has been a valuable tool to cautiously characterization of 12 flavonoid glycosides (Molecular weight: 497.04 (RT:3.586), 475.06 (RT:6.801), 393.48 (RT:12.594), 336.50 (RT:16.473), 723.00 (RT:17.774), 452.52(RT:18.253), 978.95 (RT: 25.665), 836.20 (RT: 26.889),  893.00 (RT: 27.925), 838.32 (RT: 31.592), 507.44 (RT: 31.592), 415.18, (RT:33.849) in the methanol extract of this fruit. All these flavonoid glycosides are the first time reported from fruit of Cucumis dipsaceus Ehrenb., and also highlighting the importance of this fruit as a rich source of likely flavonoid glycosides as antioxidants and hepatoprotective agent. It was concluded that these flavonoid glycosides were Myceritin -3-O- β -D-glucopyranoside  (497), Apigenin 7 – O – 6’’ – O acetyl – β – D – glucopyranoside (475),  5,6 Dihydroxy 7,8 – dimethoxyapigenin  – 6 – O – sulfate (393), 5-p-coumaroylquinic acid (336 or 338), 6’’ -O-(3-hydroxy-3- methylglutaroyl)-2’’ – O – pentosyl-C – hexosyl-luteolin  (723), Catechin-3-O-glucoside (452), 3’,4’,5’,5,7 – Methyl derivative of quercetin 3 – O – (2” – feruloylglucosyl)(1->6) – [apiosyl1->2)] glucoside (978.859), Quercetin 3 – O – β – D -(6 – O – sinnapoyl – 2 – O – – O – β – D glucopyranosyl) glucopyranoside (833), Apigenin 7-O-(6”-dihydrogalloyl)-glucosyl-8-C-rhamnosyl-6-C-glucoside  (893), precursor or isomer ion of Quercetin 3 – O – β – D -(6 – O – sinnapoyl – 2 – O – – O – β – D glucopyranosyl) glucopyranoside 838.32 , 3’,4’,7 – Methyl derivative of quercetin 3 – O – β – D – glucopyranoside (507) and 415 (Daidzein 7 – O – glucoside).

4. Investigation of Green Synthesized Silver Nanoparticles Using Aqueous Leaf Extract of Artemisia Argyi for Antioxidant and Antimicrobial Potentials
Anto Cordelia T A D, Hng Huey Ping
The current study employs green synthesis to acquire silver nanoparticles (AgNPs) using Artemisia argyi and appraise their antioxidant and antimicrobial potentials. AgNPs were synthesized using aqueous leaf extract of Artemisia argyi by sunlight irradiation. They were characterized using UV-visible spectrophotometer, FESEM, FTIR and XRD. The antioxidant capacity of AgNPs were evaluated using ABTS, DPPH, iron chelation, FRAP and NO radical scavenging methods. Antimicrobial activities of AgNPs were tested against Esherichia coli and Staphylococcus aureus using disc diffusion method. Descriptive statistical analysis was used to identify significant relationship between antioxidant activities of AgNPs. The synthesized AgNPs exhibited brown color light scattering and absorbed maximum wavelength of light at 450 nm. The synthesis of AgNPs was optimum at 0.01 M AgNO3. The green synthesized AgNPs were spherical in shape with size ranging from 16 nm to 32 nm. The FTIR analysis revealed the presence of proteins, phenolic and polar nitrile compounds in the AgNPs. The purified AgNPs possessed a face centered cubic structure with coexistence of silver chloride crystals. The total phenolic and flavonoid of AgNPs were found to be 77.45 mg GAE/g AgNPs and 205.29 mg GAE/g AgNPs respectively.  The radical scavenging activity (EC50) showed highest activity for NO (31.33 µg/ml) followed by ABTS (128.82 µg/ml), DPPH (263.03 µg/ml) and Fe2+ (1445.44 µg/ml) with a FRAP value of 1.22 mmol Fe2+ /mg dry weight. AgNPs possessed inhibitory effect against both strains of bacteria in concentration dependent manner. This study discovered that green synthesized AgNPs using Artemisia argyi are promising sources of effective antioxidants and antimicrobial agents with a high surface area catalytic activity.

5. Cyclamen persicum: Methanolic Extract Using Gas Chromatography-Mass Spectrometry (GC-MS) Technique
Israa Adnan Ibraheam, Haider Mashkoor Hussein, Imad Hadi Hameed
Cyclamen was traditionally classified in the family Primulaceae, was reclassified in the subfamily Myrsinoideae within the family Primulaceae. The objective of this study was analysis of the secondary metabolite products. Bioactives are chemical compounds often referred to as secondary metabolites. Thirty eight bioactive compounds were identified in the methanolic extract of Cyclamen persicum. The identification of bioactive chemical compounds is based on the peak area, retention time molecular weight and molecular formula. GC-MS analysis of Cyclamen persicum revealed the existence of the3-Oxo-androsta-1,4-dien-17β-spiro-2′-3′-oxo-oxetane , 3,5-Dithiahexanol 5,5-dioxide , 1-(2-Nitrophenyl)piperazine , Oxime-,methoxy-phenyl- , Cyclohexene , 1-methyl-4-(1-methylethenyl)-,(S)- , D-Limonene , Fumaric acid ,3-methylbut-3-enyl undecyl ester , Geranyl vinyl ether , 3,6,9,12-Tetraoxatetradecan -1-ol,14-[4-(1-,1,3,3-tetramethylbu , Cis-5,8,11,14,17-Eicosapentaenoic acid , α-Terpineol , 3-Allyl-6-methoxyphenol , 3-Cyclohexene-1-methanol,α,α,4-trimethyl-,acetate , Orcinol , 4,5-di-epi-aristolochene , Trans-calamenene ,  3-(N,N-Dimethyllaurylammonio)propanesulfonate , Deoxyqinghaosu , Atranorin , N-[4-(4-Chlorophenyl)isothiazol-5-yl)-1-methylpiperidin-2-imine ,  10-Heptadecen-8-ynoic acid , methyl ester , (E)- , 2-Pentadecanone ,6,10,14-trimethyl- , Caffeine , 4,4,8-Trimethyltricyclo[]dodecane-2,9-diol , Bufa-20,22-dienolide , 3,14-dihydroxy-,(3β,5β)- , 1-(3-methyl-2-butenyl)-3,6-diazahomoadamantan-9-ol , 9,12-Octadecadienoic acid (Z,Z)-, methyl ester , 9-Octadecenamide,(Z)- , 9,10-Secocholesta -5,7,10(19)-triene-3,24,25-triol,(3β,5Z,7E)- , Tributyl acetylcitrate , Cyproheptadine , 3,9-Epoxypregn-16-en-20-one , 3-methoxy-7,11,18-triacetoxy- , 17-Pentatriacontene , Phthalic acid , bis(7-methyloctyl) ester , Phthalic acid , di(6-ethyl-3-octyl) ester , Ergosterol , γ-Sitosterol and Friedelan-3-one

6. Studying Strategies for Implementing Quality Culture in  Pharmaceutical Organizations
D Raghavendra, R K Chauhan, T D mallikarjuna
Quality culture implementation in pharmaceutical firm increasingly face challenges to ensuring that patients are provided with medications that are safe, effective and produced at a high level of quality. Despite recent advances in the manufacturing sector quality issues remain frequent occurrence and can result in recalls, withdrawals or harm to patients. A number of strategies have been utilized in various pharmaceutical firms to ensure quality culture for high quality drug products. However, a synthesis of the literature on these strategies has not previously been undertaken. Methods: We reviewed articles published in following websites that assessed and studied interventions for implementing quality culture in pharmaceutical companies and other i.e. non-pharmaceuticals companies. We organized the intervention in each study into three groups: Interventions aiming to increase involvement and empower of employees. Interventions aiming to transform management philosophy on quality culture i.e. Doing right and not what is easy in business. Combined employee and management interventions. We summarized the main quantitative outcomes from each study and effective practices from each intervention category. Results: Ten studies were identified; one described interventions designed to improve employee’s perspective and engagement towards quality culture, one described interventions that aimed to increase management involvement day-to-day quality culture and eight studies aiming to improve both availability of employees and management participation and engagement in quality culture roll-out and implementation. All studies reported positive change. Conclusions: Few studies have assessed interventions designed explicitly for the unique challenges facing quality culture roll-out in pharmaceutical firms. Further research on sustainability, scalability and cost effectiveness of interventions is needed to fill this gap.

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This journal is present in UGC approved List of Journals for the purpose of Career Advancement Scheme (CAS) and Direct Recruitment of Teachers and other academic staff as required under the UGC (Minimum Qualifications for Appointment of Teachers and other Academic Staff in Universities and Colleges)

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