DEVELOPMENT AND VALIDATION OF NOVEL RP-UPLC METHOD FOR ESTIMATION OF ATROPINE SULPHATE IN PHARMACEUTICAL DOSAGE FORM

A simple, precise, accurate, sensitive and repeatable RP-UPLC method was developed for quantitative determination of atropine sulphate in pharmaceutical dosage form. The method was developed by using a C-18 column Hiber HR Purospher Star (100 mmx2.1 mm id, 2 pm particle size) as stationary phase with phosphate buffer:acetonitrile (87:13, v/v) as a mobile phase; pH was adjusted to 3.5 by orthophosphoric acid at a flow rate of 0.5 mL/min and the column temperature was maintained at 30 degrees C. Quantification of the eluted compound was achieved with a PDA detector at 210 am. Atropine sulphate followed linearity in concentration range of 2.5-17.5 mu g/mL with r(2) = 0.9998 (n = 6). Limit of detection (LOD) and limit of quantification (LOQ) values were 0.0033 and 0.0102 mu g/mL for atropine sulphate. The validation study was carried out as per International Conference on Harmonization (ICH) guidelines. This method was successfully applied for the estimation of atropine sulphate in pharmaceutical formulation.