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Authors
Affiliations
1 Dr.Reddy’s Laboratories Ltd, Bachupally, Hyderabad, Andhra Pradesh, IN
2 United States Pharmacopeia-India Pvt. Ltd, ICICI Knowledge Park, Turkapally, Shameerpet, Hyderabad, IN
3 KrishnaTeja Pharmacy College, Tirupathi, Chittor (Dt), Andhra Pradesh, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 1, No 1 (2011), Pagination: 3-7
Abstract
A novel stability indicating liquid chromatographic assay method was developed and validated as per ICH guide lines for the quantitative estimation of Aripiprazole in tablet formulation. An isocratic reverse phase LC-method was developed using Phenomenex Luna C18, 150 x 4.6mm, 5μm column and a mobile phase comprising of Acetonitrile and Phosphate buffer, 0.05M (40:60 v/v). The detector set at 227nm with flow rate of 1.0mL min-1. The method is Linear in rage of 25μg mL-1 to 200 μg mL-1. The Accuracy of the method was found to be in the range of 99.95% to 100.0%. The mean Inter and Intraday assay Relative Standard deviation (%RSD) were less than 1.0%. The Analyte and mobile phase were stable up to 48hours. The Proposed method was found to be Linear, precise and accurate for the quantitative estimation of Aripiprazole in tablet formulations and can be used for commercial purposes.
Keywords
Aripiprazole, Liquid Chromatography, Stress Degradation and Method Validation.
