Analytical Method Development and Validation of Stability Indicating Assay Method for Estimation of Olmesartan Medoxomil and Hydrochlorothiazide in Dosage Form by RP-HPLC
DOI:
https://doi.org/10.61096/ijpar.v10.iss2.2021.180-186Keywords:
Hydrochlorothiazide, Olmesartan medoxomil, RP-HPLC, Stability indicating method.Abstract
To develop a rapid, precise, accurate and sensitive reverse phase High Performance liquid chromatography method and Forced degradation studies for the estimation of Olmesartan medoxomil and Hydrochlorothiazide in dosage form. Method was performed on C18column (INERTSIL ODS 3V, 5µ, 150*4.6mm) using a mobile phase consisting of pH 3.0 phosphate buffer: Acetonitrile at a flow rate of 1.0 ml/min with UV detection at 262nm.drugs was subjected to UV degradation, Thermal Degradation, Humidity Degradation, Acid degradation, base degradation, Peroxide degradation and Neutral degradation respectively. This method is validated by using various validation parameters like system suitability, specificity, linearity, precision, accuracy, solution stability, filter interference and robustness. The retention time of Hydrochlorothiazide peak was at 5.242 and Olmesartan peak was at 8.480 respectively. The calibration curve of Hydrochlorothiazide was linear over the range of 15-90 µg/ml and Olmesartan medoxomil 24-144µg/ml respectively. Correlation coefficient was obtained at 0.999 for Olmesartan medoxomil and Hydrochlorothiazide respectively. The limits of detection of Hydrochlorothiazide and Olmesartan medoxomil were determined 1.18µg/ml and 0.754µg/ml. And limits of quantification of Hydrochlorothiazide and Olmesartan medoxomil were determined 3.58µg/ml and 2.28µg/ml respectively. The study show to facilitate the reverse phased liquid chromatography is sensitive and selective for detecting Hydrochlorothiazide, Olmesartan and its impurities using the gradient programme.