Development of Validated Stability Indicating RP-HPLC Method for Amisulpride Injection

Deore . T.N.; Pawar S.S; Bachhav P.M.

Abstract

Objective of the present work is to develop and validate a simple, cost effective, sensitive and fast RPHPLC method for the analysis of Amisulpride injection. A Waters HPLC system with Octacysilane 150 mm × 4.6 mm column is employed for the analysis using pH 4.5 phosphate buffer solution, acetonitrile and methanol in the ratio of (75:20:5 v/v) as mobile phase. Signal from Amisulpride is detected at 280 nm by UV Spectrophotometer. The proposed method is fully validated and found to be linear over a workable drug concentration, accurate, precise and robust. This is fast and inexpensive method and also this method is Equivalent to UPLC. It is suitable for research laboratories as well as for quality control analysis in pharmaceutical industries.

Abstract

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