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.
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.
Capecitabine is a prodrug of 5-fluorouracil, employed as a monotherapy or combination chemotherapy agent for treatment of colorectal cancer. Combination therapy of capecitabine consists of oxaliplatin, and hence, it becomes essential to determine that co-administration does not affect its metabolism. High-performance liquid chromatography and high-performance thin-layer chromatography methods were developed and validated to determine the plasma concentration of capecitabine. In this study, blood samples from 12 patients with colorectal cancer were collected and analyzed by both methods with a reference internal standard. Two groups consisting of six patients each were formed: the first group was treated with capecitabine monotherapy, the second group with capecitabine + oxaliplatin combination therapy. The results of analysis from both the methods indicated that there is no significant drug–drug interaction. The co-administration of oxaliplatin did not affect the metabolism of capecitabine. Both assay methods were compared for their sensitivity, robustness and specificity. It was found that both the assay methods were suitable for therapeutic drug monitoring of capecitabine.
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