Development and Validation of Stability Indicating Rapid Hplc Method for Estimation of Ivabradine Hydrochloride in Solid Oral Dosage Form

Objective: A simple, rapid, accurate, linear, precise, specific, robust, rugged and stability indicating high performance liquid chromatography (HPLC) method has been developed for estimation 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, 5 μm), 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 stability indicating capability of the method was proven by subjecting the drug to stress conditions as per ICH recommended test conditions such as acid and alkali hydrolysis, oxidation, photolysis, thermal and humidity degradation. 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 stability indicating and specific. The % RSD value was 0.48% for method precision. Ruggedness of the method is indicated by the overall RSD values of 0.52 % for Ivabradine hydrochloride. The linearity of response for Ivabradine hydrochloride was determined over the range 70.69 to 131.29 μg/ml with correlation coefficient of 0.99974. The mean accuracy of triplicate samples of three different levels was found at 99.03% with %RSD of 0.38%. 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. This method can also used for LCMS analysis as mobile phase is LCMS compatible.