Abstract

VALIDATION AND FORCED STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF AZELNIDIPINE

Akshay S. Rane* and Prof. Dr. Sunil K. Mahajan

Abstract

Azelnidipine is a antihypertensive agent. The technique for the forced degradation was successfully applied for the development of stability indicating HPTLC method for the estimation of Azelnidipine on the plates precoated with silica gel 60 F254. The mobile phase used was Chloroform: Ethyl Acetate: Methanol in the ratio of 6.5:3.5:0.1 v/v/v. The drug showed absorbance maxima at 255nm. Forced degradation study of Azelnidipine was carried out according to the international conference of harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid/base hydrolysis, oxidation, thermal and photolysis degradation. There was no interference between the drug peak and peak of degradation product; therefore the method was found to be specific for the determination of Azelnidipine in the presence of the degradation product. This system showed Rf value of 0.48±0.02 for Azelnidipine. The data of linearity indicated a good linear relationship over the range of 300–800 ng/band concentrations. The LOD and LOQ were 58.035 and 175.86 ng/band, respectively. Under different stressed conditions, Azelnidipine showed degradation product only under acidic hydrolysis at Rf value of 0.44 ± 0.02.

Keywords: Azelnidipine, high-performance thin layer chromatographic (HPTLC) method, Stability-Indicating Method.