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Development and Validation of RP-HPLC Method for Estimation of Amlodipine Besylate and Celecoxib in Pharmaceutical Formulation

机译:RP-HPLC方法估算药物制剂中氨氯普酸盐和塞克西布的研制与验证

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A simple, precise, accurate, and rapid reverse phase-high performance liquid chromatography (RP-HPLC) method with UV-Visible detector has been developed and subsequently validated for the simultaneous determination of amlodipine besylate(AML) and celecoxib(CEL) in their combined tablet dosage form. The separation was based on the use of a Flowrosil C 18 analytical column (250 × 4.6 mm, i.d., 5 μm). The mobile phase consisted of a mixture of 80 volumes of acetonitrile and 20 volumes of water. The chromatography was performed by isocratic elution at a flow rate of 1 mL/min. Analytes were detected at 250 nm, with linear calibration curves at concentration ranges of 2-12 μg/ml and 50-300 μg/ml for AML and CEL respectively. The retention time of AML and CEL were 1.98 and 3.15 min respectively. The recoveries obtained were 99.46?101.36% for AML, 99.57?101.42% and 99.96–100.87 % for CEL. The method was validated according to International conference of harmonisation guidelines in terms of accuracy, precision, specificity, robustness, limits of detection and quantitation, and other aspects of analytical validation. The developed method was applied successfully for HPLC analysis of commercial pharmaceutical products including AML and CEL.
机译:已经开发了一种简单,精确,准确,快速的反相 - 高性能液相色谱(RP-HPLC)方法,并随后验证了同时测定其氨氯普林酸盐(AML)和Celecoxib(Cel)组合片剂剂型。分离是基于流通C18分析柱(250×4.6mm,I.D.,5μm)的使用。流动相由80体积的乙腈和20体积水的混合物组成。通过以1mL / min的流速进行的等物质洗脱来进行色谱。在250nm下检测分析物,分别在2-12μg/ ml的浓度范围内的线性校准曲线,分别为50-300μg/ ml,分别为AML和CEL。 AML和CEL的保留时间分别为1.98和3.15分钟。得到的回收率为99.46〜101.36%,99.57〜101.42%和99.96-100.87%。该方法是根据统一指南国际会议的验证,精确,精确,特异性,鲁棒性,检测和定量限制以及分析验证的其他方面。已成功应用开发方法,用于商业药品的HPLC分析,包括AML和CEL。

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