A NOVEL STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF NEBIVOLOL AND INDAPAMIDE IN BULK AND PHARMACEUTICAL FORMULATIONS

Abstract

A simple, precise, accurate, reproducible and economical stability- indicating reverse phase liquid chromatography method was developed and validated for the quantitative simultaneous estimation of nebivolol and indapamide in bulk and marketed formulations. Estimation of drugs in this combination was done with a C18 column [Kromasil column. 250mm × 4.5 mm] using mobile phase of composition acetonitrile and phosphate buffer (60:40 V/V, pH 3). The flow rate was 0.8 ml/min and the effluents were monitored at 226nm. The retention time of nebivolol and indapamide were 2.9 min and 4.2 min, respectively. The method was found to be linear over a range of 10-50 μg/mL for nebivolol and 2-10 μg/mL for indapamide. The established method proved as reproducible one with a % RSD value of less than 2 and having the robustness and accuracy within the specified limits. Assay of marketed formulation was determined and found to be 99.08% and 99.87% for nebivolol and indapamide, respectively. The stressed samples were analyzed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully employed in the estimation of commercial formulations. This liquid chromatographic method can be applied for the qualitative and quantitative determination of selected drugs by the modern chemist.