Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ACOTIAMIDE HYDROCHLORIDE USING REVERSE PHASE HPLC METHOD IN BULK AND TABLET DOSAGE FORM

Dr. R. Vani* and Dr. M. Sunitha

ABSTRACT

A new method was established for Acotiamide by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Acotiamide by using Agilent C18 column (4.6×150mm) 5μ, flow rate was 1ml/min, mobile phase ratio was (60:40 v/v) Methanol: Acetonitrile, detection wavelength was 235nm. The instrument used was Waters HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.825 mins. The % purity of Acotiamide was found to be 100.27%. The system suitability parameters for Acotiamide such as theoretical plates and tailing factor were found to be 4023 and 1.4. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Acotiamide was found in concentration range of 20ppm-100ppm and correlation coefficient (r2) was found to be 0.999, % recovery was found to be 100.56%, %RSD for repeatability was 0.17, % RSD for intermediate precision was 0.1. The precision study was precision, robustness and repeatabilty. LOD value was 0.303μg/mL and LOQ value was 1.011μg/ml. Hence the suggested RP-HPLC method can be used for routine analysis of Acotiamide in API and Pharmaceutical dosage form.

Keywords: Acotiamide C18, Acotiamide, RP-HPLC.