反相高效液相色谱法同时测定原料药和制剂中阿米替林和哌那嗪含量的新方法的建立与验证

International Journal of Research in Pharmaceutical Sciences and Technology Pub Date : 2018-05-23 DOI:10.33974/ijrpst.v1i1.19

V. P. Kumar, B. Ramadevi, S. Karishma, P. Divya, B. Sivagami, M. Niranjan

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引用次数: 0

摘要

建立了一种简便、精确、准确、重现性好的反相高效液相色谱(RP-HPLC)方法，用于同时测定原料药和制剂中阿米替林和Perphenazine的含量。在Inertsil ODS (250x4.6mm) 5µm色谱柱上，采用甲醇:ACN:水(50:30:20)等密度模式，流速为1.0 ml/min，成功分离阿米替林和Perphenazine，在253nm处监测，阿米替林和Perphenazine的保留时间分别为2.440和5.503 min。对该方法进行了验证，结果表明该方法是线性的。阿米替林和奋那嗪的相关系数分别为0.992和0.9992。苯丙嗪和阿米替林的检出限分别为33.8µg/ml和4.2µg/ml。Perphenazine和Amitriptyline的定量限分别为20.88µg/ml和12.12µg/ml。阿米替林和奋那嗪的加样回收率均在限定范围内，表明该方法准确度高。根据ICH指南对该方法进行了广泛的验证。

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Development and validation of new analytical method for the simultaneous estimation of amitriptyline and perphenazine in bulk and pharmaceutical dosage form by RP-HPLC

A new, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Amitriptyline and Perphenazine in bulk and pharmaceutical formulations was developed. Separation of Amitriptyline and Perphenazine was successfully achieved on Inertsil ODS (250x4.6mm) 5µm column in an isocratic mode utilizing Methanol: ACN: Water (50:30:20) at a flow rate of 1.0 ml/min and eluents were monitored at 253nm with a retention time of 2.440 and 5.503 minutes for Amitriptyline and Perphenazine respectively. The method was validated and it was found to be linear. The values of the correlation coefficient were found to 0.992 for Amitriptyline and 0.9992 for Perphenazine respectively. The LOD for Perphenazine and Amitriptyline were found to be and 33.8µg/ml and 4.2 µg/ml. The LOQ for Perphenazine and Amitriptyline were found to be 20.88µg/ml and 12.12µg/ml respectively. The percentage recoveries for Amitriptyline and Perphenazine were found to be within the limit indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines.

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International Journal of Research in Pharmaceutical Sciences and Technology

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