Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION OF ATROPINE SULPHATE IN ATROPINE SULPHATE INJECTION

Aiswarya G.*, Radhika G., Patel Sejalben Nagindas and Baiju Mathews

.

Abstract

Objective of the present analytical research work was to develop and validate High Performance Liquid Chromatographic method (HPLC Method) for the estimation of Atropine sulphate in pharmaceutical injectable dosage form. The HPLC method for Atropine sulphate was developed using Shimadzu, C18 (150mm×4.6mm, 3μm) column as stationary phase and Buffer: Methanol (40:60 v/v, pH 5.5) as mobile phase. Mobile phase was maintained at a flow rate of 1.0ml/min and detection was carried out at 210nm. Atropine sulphate was found to be linear in the concentration range of 20-120μg/ml by HPLC. The amount of Atropine sulphate in marketed formulation by HPLC method was found to be 97.33-98.33%. The method validation data obtained showed excellent results for precision, linearity, robustness and the method is simple, less expensive and can be used for routine quality control and stability studies.

Keywords: Atropine sulphate injection, HPLC method validation, Precision, Linearity.