DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF BENIDIPINE HCL AND NEBIVOLOL HCL IN BULK DRUG AND TABLET FORM
Kudaravalli Sreedevi*, Maliha Masrath, Sadia Tabassum and Anupama Koneru
ABSTRACT
The present study is aimed towards the evaluation of fixed dose combination of two anti-hypertensive agents in combination in formulation and bulk by a RP-HPLC method and the stability evaluation is done according to ICH guidelines. The method proposed utilizes a WATERS C18 column and the mobile phase consisting K2HPO4: Methanol (55:45) adjusted to pH 5.5, with PDA detection at 248 nm. Flow rate was maintained at 1 ml/min and the analysis was carried out at ambient temperature. The run time was 6 minutes and flow rate maintained was 10 μl. With the above parameters as optimized, the method validation parameters were established within the acceptable criteria. Recovery levels of drugs was known to be >100% for benidipine and nebivolol, while the precision in terms of standard deviation was known to be 0.53 and 0.28 respectively. % RSD for system suitability was found to be 0.2% and 0.1% for benidipine and nebivolol respectively. Linearity and range of the method was found in the concentrations of 2-6 μg/ml and 2.5-7.5 μg/ml for benidipine and nebivolol respectively. Robustness of the method was analyzed with the slight modification in the parameters. Stability assessment and degradation studies under assorted conditions was carried out, which is an indicative of the shelf life of the drug. Hence, the proposed method is said to be efficient, selective, robust for the analysis of above said drugs in both forms.
Keywords: Benidipine, Nebivolol, RP-HPLC, Validation, Stability indicating.
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