Development of Validated Stability-Indicating Chromatographic Method for the Determination of Nebivolol and Valsartan and its Related Impurities in Pharmaceutical Tablets

Abstract

Vaishali Gohel59990*, Sejalben Patel59991 and Ujashkumar Shah59992

A simple, economical, precise, and selective Reverse gradient Phase High-Performance Liquid Chromatography (RP-HPLC) method has been validated and developed to estimate related impurities of Nebivolol (NEB) and Valsartan (VAL) in a tablet dosage form. A RP-HPLC analysis was performed on Hypersil BDS C18 column, and its size was 250 mm × 4.6 mm, 5 μm with using mobile phase Acetonitrile and Potassium dihydrogen phosphate (KH₂PO₄) with buffer pH-3.0 in the ratio of (50:50) at 282 nm detection wavelength with the flow rate of 1.0 mL/min. The analytical method was validated according to International Council for Harmonisation (ICH) guidelines. The linearity was observed in the Limit of 25-75 μg/ml range for Nebivolol and 1-15 μg/ml range for its related impurity A and B. Similarly, the 400-1200 μg/mL range was observed linearity for Valsartan. The correlation coefficient was more than 0.990 for Nebivolol, its related impurity A and B and Valartan. The % recovery value was found to be a minimum of 101.05% and a maximum of 102.07% for Nebivolol impurity A. Similarly, the % recovery value was found to be a minimum of 100.36% and a maximum of 100.87% for Nebivolol impurity B. The relative standard deviation value for repeatability, interday precision, and intraday precision was less than 5%. The Limit of Detection (LoD) value was found to be 0.017 μg/mL for Nebivolol, 0.378 μg/mL for its related impurity A and 0.071 μg/mL for its related impurity B. The LoD value was found 3.240 μg/mL for Valsartan. The LoQ value was found at 0.051 μg/ mL for Nebivolol, 1.147 μg/mL for its related impurity A and 0.216 μg/mL for its related impurity B. The LoQ value was found 9.820 μg/mL for Valsartan. The proposed method was found to be specific, linear, sensitive, precise, accurate, and robust in nature.