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首页> 外文期刊>International Journal of Pharmaceutical Sciences and Research >STABILITY INDICATING RP-UPLC-DAD METHOD FOR DETERMINATION OF METFORMIN AND CANAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM
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STABILITY INDICATING RP-UPLC-DAD METHOD FOR DETERMINATION OF METFORMIN AND CANAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM

机译:稳定性,指示RP-UPLC-DAD方法,用于测定批量和片剂剂型中的二甲双胍和蜜胶蛋白

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摘要

The objective of the present work is to develop and validate a novel stability-indicating RP-UPLC-DAD method for the simultaneous analysis of Metformin and Canagliflozin in bulk and tablet dosage form. The chromatographic separation was accomplished on a Waters UPLC system equipped with autosampler and PDA detector. A volume of 5 μL of sample or standard was injected into the column and the analytes were separated by using the mobile phase containing mixture of 0.1% orthophosphoric acid buffer (pH adjusted to 3.0 with 0.1 N NaOH) and acetonitrile in the ratio 30:70% v/v at a flow rate of 0.25ml/min through C18 BEH (Ethylene Bridged Hybrid) UPLC (100 mm × 2.1 mm 1.7 μm) at 55 °C column temperature and the detector wavelength was set at 260 nm. Peak area and retention time of Metformin and Canagliflozin were found to be 651341 & 332544, 0.994 & 1.508 respectively. Regression analysis shows r value greater than 0.999 for Metformin and Canagliflozin. Percent recovery of Metformin and Canagliflozin was found to be 99.94 %-100.16% & 100.17%-100.68%, respectively. The developed RP-UPLC method was validated with regard to system suitability, linearity, robustness, accuracy, precision, LOD, LOQ and forced degradation studies.
机译:本作工作的目的是开发和验证一种新的稳定性指示RP-UPLC-DAD方法,用于同时分析批量和片剂剂型中的二甲双胍和蜜蜜醇。在配备有自动进样器和PDA检测器的水域UPLC系统上完成了色谱分离。将体积为5μl样品或标准物注入塔中,分析物通过使用含0.1%正磷酸缓冲液的混合物(用0.1N NaOH调节至3.0的pH调节至3.0)和乙腈以30:70的乙腈分离在55°C柱温度下以0.25ml / min的流速为0.25ml / min的流速,以55°C柱温度,检测器波长为260nm,以0.25ml / min的流速(100mm×2.1mm1.7μm)。发现二甲双胍和蜜菌石素的峰面积和保留时间分别为651341&332544,0.994和1.508。回归分析显示二甲双胍和蜜碳增素的R值大于0.999。据发现二甲双胍和蜜菌石素的百分比分别为99.94%-100.16%和100.17%-100.68%。关于系统适用性,线性度,鲁棒性,准确性,精度,LOD,LOQ和强制退化研究,验证了开发的RP-UPLC方法。

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