A Novel Stability Indicating RP-HPLC Method Development and Validation for The Simultaneous Estimation of Losartan Potassium, Ramipril and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Form

Eurasian Journal of Analytical Chemistry

B. Venketeswara Rao¹  S. Vidyadhara¹  RLC Sasidhar¹  T.N.V.Ganesh Kumar Md.Rokiya¹ 

关键词: : Losartan Potassium;    Ramipril;    Hydrochlorothiazide;    RP-HPLC;    Stability and Method validation;   

DOI  :  10.12973/ejac.2016.139a

学科分类：分析化学

来源: Eurasian Journal of Analytical Chemistry

【 摘 要 】

A novel stability indicating reverse phase liquid chromatographic method has been developed for the simultaneous estimation of Losartan Potassium, Ramipril and Hydrochlorothiazide in bulk and Pharmaceutical formulations by using reverse phase Kromasil 100-5 C₁₈ column [250mm x 4.6mm].The mobile phase (Methanol: phosphate buffer-pH 4.0) in the ratio of 70:30% v/v was pumped at a flow rate of 0.8ml/min and the column effluents were monitored at 233nm using Variable Wavelength UV detector. Linearity was obtained in the concentration range of 100-500 µg/ml for Losartan Potassium, 10-50 µg/ml for Ramipril and 20-100µg/ml for Hydrochlorothiazide. The established method was statistically validated according to the ICH Q2B guidelines and the percentage relative standard deviation for precision, robustness and ruggedness was found to be less than 2% indicating high degree of precision and robustness. The percentage recovery for the accuracy was found to be 100.76%, 96% and 98% for Losartan Potassium, Ramipril, and Hydrochlorothiazide respectively which were within the specified limits of recovery. Assay for the marketed formulation proved that 100.76% of Losartan Potassium and 96% of Ramipril and 98.22% of Hydrochlorothiazide. The proposed analytical method was observed for various stress condition and it was proved that more stable even under acidic, alkaline, peroxide and thermal degradation conditions. Hence due to its simplicity, rapidity, precision, accuracy and stability the developed HPLC method can be applied for the estimation of Losartan Potassium, Ramipril and Hydrochlorothiazide in pure and marketed formulations by a modern analyst.

【 授权许可】

Unknown