Abstract

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF AZELNIDIPINE

Jenisha Modi, Shivangi K. Patel, Namrata Parikh, Shreya R. Shah*, Prasanna K. Pradhan and U. M. Upadhyay

Abstract

A Simple Estimated critical Spectrophotometric methods was developed according to Quality by design (QbD) approach as per ICH Q8 (R2) guidelines for estimation of Azelnidipine. QbD approach was carried out by varying various parameters and these variable parameters was designed into Ishikawa diagram. The critical parameters was determined by using principle component analysis as well as by observation. RP-HPLC method was developed for estimation of AZEL utilizing isocratic separation mode with Enable C18 (250×4.6mm.; 5 micron) column, optimum mobile phase consist of Sodium diabasic Phosphate Buffer: Acetonitrile: Methanol in the ratio of (10:50:40 v/v/v) ph adjust 4.50 by o-phosphoric acid. With effluent flow rate of 1ml/min and detecting wavelength at 257 nm in UV detector. parameters in zero order Spectrophotometric method were solvent (methanol + water), sample preparation API, Wavelength 257nm. And for first order derivative Spectrophotometric method it was sacling factor: 10 and delta lambda 4. The validation of the proposed method was found to be in compliance with the ICH guideline. For HPLC method the linearity was observed in concentration range of 2-10μg/ml for AZEL. The validation of the proposed method was found to be in compliance with the ICH guideline. The developed HPLC method was subjected to stability indicating studies for bulk formulation. Interfering peak from degraded products or solvent did not interfere with estimation of drug and the developed method was found to be specific for estimation of Azelnidipine.

Keywords: Azelnidipine, Zero Order Spectroscopy, First Order Spectroscopy, RPHPLC, Validation, Stability.