Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Quantification of 15 Organic Impurities of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide in Combined Dosage Form

摘要: A novel, simple, robust and rapid reversed-phased high performance liquid chromatographic method has been developed for the separation quantitative determination of 15 organic impurities olmesartan medoxomil, amlodipine hydrochlorothiazide in combined dosage forms. Successful five six four hydrochlorothiazide, degradation products formed under stress conditions, was achieved on Inertsil ODS-3 (100 × 4.6 mm, 3.0 μm) column, using gradient elution. The mobile phase contains 0.0 2 M phosphate buffer (pH 3.3) acetonitrile a ratio (95:05, v/v%) B 0.02 M 3.3), methanol (20:60:20, v/v/v%). Flow rate monitored at 1.8 mL min−1, UV detection carried out 237 nm. During forced studies, effect acid, base, oxidation, light temperature investigated, showing good resolution between peaks corresponding to process degradation-related impurities. validated according present ICH guidelines specificity, linearity, accuracy, precision, ruggedness robustness. To best our knowledge, this is first research paper which presents a simple HPLC method, separates all