Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ACOTIAMIDE HYDROCHLORIDE HYDRATE IN PHARMACEUTICAL DOSAGE FORM

Vinodbhai D. Ladumor*, Geeta Chaudhari, Priyanka Shah and Suleman S. Khoja

ABSTRACT

A reversed-phase high performance liquid chromatographic method has been developed and validated for estimation of Acotiamide Hydrochloride Hydrate in Pharmaceutical Dosage Form. RP-HPLC method, Column used was 150 x 4.6mm C18, Hypersil BDS with mobile phase containing: Ammonium Acetate (pH 4.5, adjust with 0.1% Tri-ethyl Amine (TEA): Acetonitrile (40:60v/v). The flow rate (1.5 ml/min) and wavelength (315 nm). The retention time was found to Acotiamide Hydrochloride Hydrate was found to be 6.697 ± 0.01 min. Correlation co-efficient for Acotiamide Hydrochloride Hydrate was found to be 0.999. Assay result of marketed formulation was found to be in 99.6 % for Acotiamide Hydrochloride Hydrate. The proposed method was validated with respect to linearity, accuracy, precision and robustness. Percentage recovery for Acotiamide Hydrochloride Hydrate was found to be 99.6 – 100.5%. Analysis proves that the developed method was successfully applied for the analysis of pharmaceutical formulations and can be used for routine analysis of drugs in Quality Control laboratories.

Keywords: Acotiamide Hydrochloride Hydrate, HPLC, AMV, ICH,Chromatography.


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