Stability Indicating Spectrophotometric and Chemometric Methods for Determination of Buflomedil in Presence of its Acid Induced Degradation Products

Abstract

Simple, accurate, sensitive, selective and validated UV spectrophotometric univariate and multivariate methods were developed for determination of Buflomedil (BFM) in presence of BFM degradation products (BFM Deg). The univariate methods includes mean centering of ratio spectra (MCR), ratio difference spectrophotometric method (RDSM) and H-point standard addition method (HPSAM); the first one used the amplitude at 235.7 nm, the second utilized the difference in amplitudes at 250 nm and 282 nm; while, the third method utilized the absorbance values at 247 and 282.4 nm. Linearity was obtained for the proposed methods in the ranges of 10–100 µgmL-1. The percentage recoveries were 100.06±0.963, 100.17±0.962 and 100.90±0.667 for the three methods in a respective order. Multivariate methods involves the application of three chemometric techniques, and classical least square (CLS) principal component regression (PCR) and partial least-squares regression (PLS), which were used for the simultaneous determination of the BFM and its degradation products. The results obtained from the proposed methods, together with the reported one, were statistically compared using one-way analysis of variance (ANOVA). These methods are suitable as stability indicating methods for the determination of BFM in presence of its degradation products either in bulk powder or in pharmaceutical formulations.