反相高效液相色谱法和紫外分光光度法测定药物制剂中的吡非尼酮

RP-HPLC and UV Spectrophotometric Methods for Estimation of Pirfenidone in Pharmaceutical Formulations.

作者信息

Parmar V K, Desai S B, Vaja T

机构信息

Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar-388120, India.

出版信息

Indian J Pharm Sci. 2014 May;76(3):225-9.

PMID:25035534

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4090830/

Abstract

High-performance liquid chromatographic and UV spectrophotometric 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 a reversed-phase C18 Zorbax Eclipse plus column with mobile phase consisting of acetonitrile:water (35:65 %v/v) at flow rate of 0.7 ml/min. The UV spectrophotometric determinations were performed at 317 nm using methanol as a solvent. The proposed methods were validated according to International Conference on Harmonization ICH Q2 (R1) guidelines. The linearity range for pirfenidone was 0.2-5.0 and 3-25 μg/ml for HPLC and UV method, respectively. Both the methods were accurate and precise with recoveries in the range of 98 and 102 % and relative standard deviation <2 %. The developed methods were successfully applied for determination of pirfenidone in tablets.

摘要

已开发并验证了高效液相色谱法和紫外分光光度法，用于定量测定吡非尼酮，一种用于特发性肺纤维化的新型抗纤维化药物。色谱分析采用等度洗脱技术，在反相C18 Zorbax Eclipse plus柱上进行，流动相为乙腈：水（35:65 %v/v），流速为0.7 ml/min。紫外分光光度法测定在317 nm波长下进行，以甲醇为溶剂。所提出的方法根据国际协调会议ICH Q2 (R1)指南进行了验证。吡非尼酮的线性范围，HPLC法为0.2 - 5.0 μg/ml，紫外法为3 - 25 μg/ml。两种方法均准确、精密，回收率在98%至102%之间，相对标准偏差<2%。所开发的方法成功应用于片剂中吡非尼酮的测定。