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Development and Validation of an HPLC Method for the Analysis of Sirolimus in Drug Products

机译:药品中西罗莫司分析的高效液相色谱法的建立与验证

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摘要

>Purpose: The aim of this study was to develop a simple, rapid and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method for quantification of sirolimus (SRL) in pharmaceutical dosage forms. >Methods: The chromatographic system employs isocratic elution using a Knauer- C18, 5 mm, 4.6 × 150 mm. Mobile phase consisting of acetonitril and ammonium acetate buffer set at flow rate 1.5 ml/min. The analyte was detected and quantified at 278nm using ultraviolet detector. The method was validated as per ICH guidelines. >Results: The standard curve was found to have a linear relationship (r2 > 0.99) over the analytical range of 125–2000ng/ml. For all quality control (QC) standards in intraday and interday assay, accuracy and precision range were -0.96 to 6.30 and 0.86 to 13.74 respectively, demonstrating the precision and accuracy over the analytical range. Samples were stable during preparation and analysis procedure. >Conclusion: Therefore the rapid and sensitive developed method can be used for the routine analysis of sirolimus such as dissolution and stability assays of pre- and post-marketed dosage forms.
机译:>目的:本研究的目的是开发一种简单,快速,灵敏的反相高效液相色谱(RP-HPLC)方法,用于定量药物剂型中的西罗莫司(SRL)。 >方法:色谱系统采用5 mm,4.6×150 mm Knauer-C18等度洗脱。流动相由乙腈和乙酸铵缓冲液组成,流速设定为1.5 ml / min。使用紫外检测器检测分析物并在278nm处定量。该方法已按照ICH指南进行了验证。 >结果:发现标准曲线在125–2000ng / ml的分析范围内具有线性关系(r 2 结论:因此,开发的快速灵敏的方法可用于西罗莫司的常规分析,例如上市前和上市后剂型的溶出度和稳定性测定。

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