Abstract

DEVELOPMENT AND VALIDATION OF RAPID RP-HPLC METHOD FOR DISSOLUTION RELEASE OF IVABRADINE HYDROCHLORIDE IN SOLID ORAL DOSAGE FORM

Selva Kumar P, Pandiyan K, Rajagopal K

ABSTRACT

Objective: A simple, rapid, accurate, linear, precise, specific, robust and rugged high performance liquid chromatography (HPLC) method has been developed for dissolution of Ivabradine hydrochloride from solid oral dosage form. Methods: The chromatographic separation was obtained using a mobile phase composition at a ratio of 50:50 (v/v) of 10 mM ammonium acetate buffer pH 6.0 and methanol on Phenomenex Kinetex C18 column (150 × 4.6 mm, 5μm), ambient temperature with UV detection at 285 nm at a flow rate of 1.0 ml/minute. The retention was at 3.1 mins. Results: The method was validated according to ICH guidelines. The system suitability parameters such as theoretical plate count, tailing and percentage RSD between six standard injections were within the limit. The peak purity plots show that the Ivabradine hydrochloride peak is homogeneous and that there are no co eluting peaks indicating that the method is specific. The % RSD value was 1.02% for method precision. Ruggedness of the method is indicated by the overall RSD values of 0.92 % for Ivabradine hydrochloride. The linearity of response for Ivabradine hydrochloride was determined over the range 1.966 to 11.793 μg/ml with correlation coefficient of 0.99975. The mean accuracy of triplicate samples of three different levels was found at 100.62% with %RSD of 0.70%.The robustness of the method was evaluated by deliberately altering the chromatographic conditions.Conclusion: The analytical method validation data showed excellent results for precision, linearity, specificity, accuracy, ruggedness and robustness. The present method can be successfully used for routine quality control and stability studies.

Keywords: Dissolution,Ivabradine hydrochloride, RP- HPLC.