RP-HPLC Estimation of Ramipril and Telmisartan in Tablets

反相高效液相色谱法测定片剂中雷米普利和替米沙坦的含量

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Abstract

A rapid high performance liquid chromatographic method has been developed and validated for the estimation of ramipril and telmisartan simultaneously in combined dosage form. A Genesis C18 column having dimensions of 4.6x250 mm and particle size of 5 mum in isocratic mode, with mobile phase containing a mixture of 0.01 M potassium dihydrogen phosphate buffer (adjusted to pH 3.4 using orthophosphoric acid): methanol:acetonitrile (15:15:70 v/v/v) was used. The mobile phase was pumped at a flow rate of 1.0 ml/min and the eluents were monitored at 210 nm. The selected chromatographic conditions were found to effectively separate ramipril (R(t): 3.68 min) and telmisartan (R(t): 4.98 min) having a resolution of 3.84. The method was validated in terms of linearity, accuracy, precision, specificity, limit of detection and limit of quantitation. Linearity for ramipril and telmisartan were found in the range of 3.5-6.5 mug/ml and 28.0-52.0 mug/ml, respectively. The percentage recoveries for ramipril and telmisartan ranged from 99.09-101.64% and 99.45-100.99%, respectively. The limit of detection and the limit of quantitation for ramipril was found to be 0.5 mug/ml and 1.5 mug/ml respectively and for telmisartan was found to be 1.5 mug/ml and 3.0 mug/ml, respectively. The method was found to be robust and can be successfully used to determine the drug content of marketed formulations.

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