Capecitabine is a prodrug of 5-flurouracil, employed as a broad spectrum chemotherapeutic agent. It is also used as monotherapy or a combination chemotherapy agent for the treatment of colorectal cancer. Capecitabine is administered in combination with oxaliplatin and hence it is essential to determine that co-administration does not affect its metabolism. To determine the plasma concentration of capecitabine a simple HPTLC method was developed and validated. Blood samples from 12 patients with colorectal cancer were collected and analyzed by the HPTLC method with a reference internal standard. Out of these 12 patients, six were treated with capecitabine monotherapy and another six were treated with capecitabine + oxaliplatin combination therapy. The results of analysis indicated that there was no significant drug-drug interaction and the co-administration of oxaliplatin did not affect the metabolism of capecitabine. This method is sensitive, robust and specific and allows analysis of multiple samples simultaneously, making it suitable for therapeutic drug monitoring of capecitabine.
A rapid and sensitive reversed-phase high-performance liquid chromatographic method is developed for simultaneous estimation of fluconazole, an orally active triazole anti-fungal agent, and tinidazole, which belongs to the group of 5-nitroimidazoles in combined dose tablet. Chromatographic separation was on an ODS Hypersil C(18) column using 0.05 M potassium dihydrogen phosphate buffer (pH 3.25, adjusted with orthophosphoric acid) and acetonitrile (82:18, v/v) as the mobile phase at a flow rate of 1.5 mL/min with detection at 210 nm. The asymmetry factors are 1.36 +/- 0.04 for fluconazole and 1.26 +/- 0.07 for tinidazole with a total run time of less than 7 min. The calibration curves were linear in the range 6-14 microg/mL for fluconazole and 80-190 microg/mL for tinidazole. The method was validated with respect to linearity, precision, accuracy, and specificity. The mean recovery for fluconazole and tinidazole is 99.65 +/- 0.84 and 99.34 +/- 0.70, respectively. The utility of the procedure is verified by its application to the market formulation that was subjected to various stressed conditions. Two potential degradation products of tinidazole on exposure to alkaline stressed condition are well-resolved. The method separated the two target drugs and degradation products well. No chromatographic interference is observed.
UV, HPLC and HPTLC methods were developed and validated for the quantitative determination of Pirfenidone, a novel antifibrotic agent used in idiopathic pulmonary fibrosis. Chromatography was carried out by isocratic technique on reversed phase Eclipse XDB-C 18 column (150 x 4.6 mm, 5µm) with mobile phase consisting of phosphate buff: acetonitrile (pH 3.5) 72:28 v/v at flow rate 1mL/min. TLC was carried out by stationary phase precoated Silica Gel 60 F 254 TLC Plate using mobile phase Toluene: Methanol, 8:2 v/v. The UV spectrophotometric determination was performed at 311nm using solvent methanol. The proposed methods were validated according to ICH Q2-(R1) guidelines. The linearity range for Pirfenidone was 5-70 µg/mL for HPLC, 800-1600 ng/spot for HPTLC and 10-60 µg/mL for UV method. These methods were accurate and precise with recoveries in the range of 98.2-102.32 and relative standard deviation < 2%. The developed methods were successfully applied for determination of Pirfenidone in tablets.
Objective: Research is a systematic investigation that involves the study of materials and sources in order to establish facts and reach new conclusions. Post-graduate pharmaceutical education develops the necessary skills among students which help them build their professional carriers and contribute towards the betterment of the healthcare industry and society in general. Hence, it is essential and mandatory to carry out some appropriate research work as a requirement of post-graduate courses in Pharmaceutical Sciences in India and abroad. In an era, where technology is changing rapidly, the research carried out by students must always be relevant to the present day, so that it can act as a bridge between innovation and utility with regard to patient care and compliance. The present work aims to investigate, as to how, the research at postgraduate level in pharmacy, could be carried out in a way so that it benefits the students and make their research relevant to the current industry needs. Methods:The opinions of academicians from select academic institutions, professionals from pharmaceutical industries and postgraduates and Ph. D. students across India, were collected through questionnaires and by taking personal interviews. Data thus obtained was subjected to standard mathematical interpretations.Results: About 48% (65) of faculty members and 46% (156) of Postgraduate and Ph. D. students from various parts of the country opined that projects in postgraduate courses should be executed partly in academic institutions and partly in industries. However, about 61% (180) respondents from the pharmaceutical industry were of the view that the postgraduate students should undertake industrial projects. At the same time, some professionals were of the view that, students carrying out research work fully in the industry are many times left on their own as their industrial supervisors are unable to spare time to guide them. Conclusion:The execution of research work carried out by post-graduate students should be evenly distributed in academic institutions as well as pharmaceutical industries, under the supervision of faculty and with active inputs from the industry.
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