DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC ASSAY METHOD AND STRESS DEGRADATION STUDIES ON DAPIPRAZOLE HYDROCHLORIDE IN OPHTHALMIC DOSAGE FORM
*Kumaraswamy Gandla, K. Harathi, M. Ravinder and Gade. Narmada
ABSTRACT
A simple, rapid, accurate, precise, robust and reproducible reverse phase high performance liquid chromatographic method was developed for the determination of Dapiprazole in pure drug and pharmaceutical dosage form. The quantification was carried out using enable Inertsil ODS-3Vs column in a binary mode with mobile phase comprising of Acetonitrile: Methanol:Buffer (50:30:20) in the ratio of 50:30:20 %v/v at flow rate 1.0 mL/min, detection was carried out at 243 nm using UV-Visible detector with injection volume 20μl, the retention time was found to be 3.438min. The proposed method was validated as per ICH guidelines. The method produced linear response in the concentration range of 1-5μg/ml (R2 0.999). The recovery studies were carried out and found to be within101%. %RSD was found to be 2%. LOD and LOQ of Dapiprazole for the method were found to be 3.64μg/ml and 11.04μg/ml respectively. The proposed method was statistically evaluated and can be applied for the routine analysis, quality control of raw materials, formulation of different strengths, dissolution studies and bioequivalence studies for the same formulation of Dapiprazole.
Keywords: Dobutamine; RP–HPLC; Validation; Stability indicating: Ophthalmic Dosage form.
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