Asian Journal of Pharmaceutical Analysis

Mohan Krishna Lokireddy ¹, P. Jayachandra Reddy ², Nallathambi Ramasamy ¹, B. Prabhakar Reddy ¹

Affiliations
1 Vignan Institute of Pharmaceutical Sciences, Deshmukhi, Nalgonda, Andhra Pradesh, IN
2 Krishna Teja Pharmacy College, Tirupati, IN

Abstract

Four simple and sensitive spectrophotometric methods (A - D) for the assay of Aripiprazole in pure and dosage forms based on the formation of chloroform soluble ion-associates under specified experimental conditions are described. Four acidic dyes, namely, wool fast Blue (WFB BL, method A), orange II (Tpooo, method B), Naphthalene Blue 12 BR (NB-12BR, method C), and Azocarmine (AG, method D) are utilized. The extracts of the ion-associates exhibit absorption maxima at 580, 480, 630 and 540 nm for methods A, B, C and D, respectively. Beer's law and the precision and accuracy of the methods are checked by the UV reference.

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G. Raveendra Babu ¹, J. Srinivasa Rao ², K. Suresh Kumar ², P. Jayachandra Reddy ³

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

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.

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