NGHIÊN CỨU XÂY DỰNG VÀ THẨM ĐỊNH QUY TRÌNH ĐỊNH LƯỢNG ĐỒNG THỜI AMLODIPIN CAMSYLAT VÀ LOSARTAN KALI BẰNG PHƯƠNG PHÁP HPLC-UV/VIS

Abstract

Background: Hypertension is a major risk factor for cardiovascular complications. The combination of amlodipine and losartan potassium in treatment provides more effective blood pressure control. Several chromatographic methods have been developed for the quantitative determination of amlodipine (as besylate) and losartan potassium; however, amlodipine camsylate has not been studied. There is currently no pharmacopoeia analytical procedure for the simultaneous determination of amlodipine (camsylate) and losartan potassium, which makes testing difficult. Therefore, the development and validation of a quantitative method is necessary to assess the drug content in the preparation. Objectives: Analyze chromatographic conditions, develop, and validate a method to simultaneously quantify amlodipine camsylate and losartan potassium using high-performance liquid chromatography. Materials and methods: Experimental research method on finished film-coated tablets containing active ingredients amlodipine camsylate and losartan potassium at the same time. Results: HPLC method with UV/VIS detector, reversed phase Pursuit XRS 5 C18 (250 x 4.6 mm, 5 µm) column, the optimal mobile phase for the simultaneous analysis of amlodipine and losartan potassium was phosphate buffer at pH 2.2 and acetonitrile (ACN) in a 67:33 (v/v) ratio. The chromatographic system demonstrated system suitability requirements, with stable retention time and peak area parameters, maintaining an RSD of less than 2%. The method achieved specificity, linearity with R² > 0.998 in the concentration range of 12.52 – 43.82 μg/mL for amlodipine camsylate and 160 - 560 μg/mL for losartan potassium. Recovery was 98,0% - 102.0% with RSD < 2.0%, demonstrating high accuracy. Precision was assessed by repeatability and intermediate precision with RSD < 2.0%. Conclusion: The HPLC method with the above chromatographic conditions can be applied to simultaneously quantify drugs containing amlodipine camsylate and losartan potassium.