Stability indicatingHPLC-determination of biperiden hydrochloride in presence of its oxidative and acid degradation products

Hayam M.Lotfy, Ezzat M.Abdel-M

Abstract

A RP-HPLC method for stability indicating determination of biperiden hydrochloride (BIPER) in presence of its oxidative and /or acid degradation products, was developed, optimized, validated and appiled either in tablets dosage form or in raw materials. The separation could be acheived on a reversed phase column [NucleodureC18 (5m, 25 cmx 4.6mmi.d.)] isocratically by using amixture of 0.2%0.1N perchloric acid in 0.01Msodiumperchlorate solution and acetonitrile in a ratio (50 : 50% v/v) as the mobile phase withUV-detection at 210 nm. Significant linearitywas observed in the ranges of 8-100gmL-1. Statistical evaluation of the resultswas obtained by adopting the proposed method and those of reference ones has been undertaken by applying the student t-testing, F-ratio calculation and by one-way ANOVAassessment.