QUANTIFICATION AND VALIDATION OF AMLODIPINE BESYLATE, OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE BY RP-HPLC IN MARKETED DOSAGE FORMAbstract
The endeavor of the present work is to develop a simple, economical, efficient, novel green analytical method for the estimation of Amlodipine besylate, Olmesartan medoxomil and Hydrochlorothiazide in pharmaceutical formulation. Quantification was carried out using an Inertsil CN-3.5 μm (4.6 ×250 mm) column, where the mobile phase consisting of 10 mm Phosphate buffer (pH 3.0) and Acetonitrile (40:60). The flow rate was 1.0 mL/min and the effluent was monitored at 262 nm. The observed linearity was in the range of 5-25 µg/ml for Amlodipine (AMLO), Hydrochlorothiazide (HCTZ) and Olmesartan medoxomil (OLME) with a correlation coefficient of 0.997, 0.999 and 0.999 respectively. The proposed method was validated as per ICH guidelines in terms of linearity, accuracy, precision, robustness, and specificity, the limit of detection and limit of quantification. The method has been applied to Amlodipine, Hydrochlorothiazide and Olmesartan formulation without the interference of excipients of the formulation.
A. Patchala * and R. Nadendla
Department of Pharmaceutical Analysis, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India.
02 July 2019
09 October 2019
08 February 2020
01 May 2020