Stability Indicating HPLC Method for Estimation of S-amlodipine besylate and Nebivolol hydrochloride in Bulk Drugs and Marketed Formulation

Author(s)

Kolasani, A., Kumar, G. V. S., Puranik, S. B., Sridhar, K. A.

Author's Affiliation

Abstract

A simple, precise and stability indicating reversed phase liquid chromatographic method was developed and validated for  estimation of s-amlodipine besylate and nebivolol hydrochloride in bulk drug and marketed formulation. The separation was achieved on Zorbax C8 G (250mm x 4.6mm, 5µm) analytical column with mobile phase comprising of 0.05M Potassium di hydrogen phosphate: Acetonitrile (pH 3.0) (60:40v/v) at isocratic flow of 1.0ml/min with UV detection at 269 nm. The retention times of s-amlodipine besylate and nebivolol hydrochloride was found to be 5.2 and 6.8 minutes respectively. The method was successfully validated in accordance to ICH guidelines for accuracy, precision, specificity, linearity, ruggedness and robustness. The linear regression analysis data for calibration plots showed good linear relationship in the concentration range 0.125-0.375μg/mL for s-amlodipine besylate and 0.25-0.75 for nebivolol hydrochloride. The drugs were exposed to acidic, basic, oxidation, thermal and photolytic stress degradation conditions. The resultant stressed samples were analyzed by the proposed method and was established to provide high resolution among the degradation products and the analytes. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time and the peak purity of analyte peaks in the stressed samples was confirmed by photodiode array detector. The method could effectively separate the drug from its degradation product; it can be employed as a stability- indicating one.

Keywords

s-amlodipine besylate , nebivolol hydrochloride, RP-HPLC, Stability indicating

Cite This Article

Kolasani, A., Kumar, G. V. S., Puranik, S. B., & Sridhar, K. A. (2012). Stability Indicating HPLC Method for Estimation of S-amlodipine besylate and Nebivolol hydrochloride in Bulk Drugs and Marketed Formulation, International Journal for Pharmaceutical Research Scholars (IJPRS), 1(3), 217-223.