Development and Validation of RP-HPLC Method for Simultaneous Estimation of Nebivolol HCl and Indapamide in Tablet

The objective of the current study was to develop a simple, accurate, precise and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method with subsequent validation using ICH suggested approach for the determination of Nebivolol hydrochloride (NEBI) and Indapamide (INDA) in tablets. The proposed RP-HPLC method utilizes a C18, 5μm, 250mm × 4.6mm i.e. column in isocratic mode, mobile phase consisting of 0.074 M potassium dihydrogen phosphate and acetonitrile in the proportion of 40:60 (v/v) with 2% triethaylamine and an apparent pH adjusted to 3.0±0.1 using orthophosphoric acid. The column effluents were subjected to UV detection at 282 nm. The retention times were 3.403 min and 7.907min for NEBI and INDA respectively at a flow rate of 1.0 ml/min. The linearity of the proposed method was investigated in the range of 50-150 μg/ml (r = 0.998) for NEB and 15-45 μg/ml (r = 0.998) for INDA respectively. The percentage mean recovery was found to be 98.01 for NEBI and 97.93 for INDA. Also, the method was statistically validated as per ICH guideline.