Abstract

DEVELOPMENT AND VALIDATION OF DISSOLUTION TEST METHOD FOR ALISKIREN IN TABLET BY HPLC

Kiran N. Kale and Krishna R. Gupta*

ABSTRACT

A dissolution test method was developed and validated for the Quality control of Aliskiren in its tablet dosage form using RP-HPLC method. The dissolution condition includes USP apparatus II at a paddle rotation rate of 50 rpm and 900 mL of 0.1N HCL buffer at 37°C±0.5°C. The described method showed good results under optimized conditions. The in-vitro release was evaluated on Hyperchrom- ODS 5µ C18 column (250 X 4.6 mm) with flow rate was 1.0mL/ min and detection wavelength 280nm. The mobile phase was prepared by mixing Acetonitrile and 0.05 M KH2PO4 Buffer (45:55v/v) and pH was adjusted to 2.5 with 10% Ortho –phosphoric acid. The developed method was successfully validated according to USP Guidelines. The proposed method for dissolution test in tablet formulation showed reliable, precise, accurate results. Hence this method could be used in routine monitoring of the quality control of the Aliskiren in its tablet dosage form.

Keywords: Dissolution test; HPLC; Aliskiren; validation.