Validation of an HPLC Method for the Determination of Diclofenac Diethylamine and Three of Its Impurities in a Gel Pharmaceutical Form.

IF 1.7 4区农林科学 Q3 CHEMISTRY, ANALYTICAL

Journal of AOAC International Pub Date : 2023-11-02 DOI:10.1093/jaoacint/qsad078

Mounir El Kacemi, Aimen El Orche, Omar Elhamdaoui, Amine Laouni, Mohamed Azougagh, Khalid Karrouchi, Mustapha Bouatia, Miloud El Karbane

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引用次数: 0

Abstract

Background: Monitoring impurities in drug products is a principal requirement of pharmaceutical regulatory authorities all over the world to ensure drug safety. For this reason, there is a great need for analytical QC of dugs products.

Objective: In this study, a simple, efficient, and direct HPLC method was developed for the determination of three impurities of diclofenac.

Methods: The HPLC method was developed using a mobile phase which consisted of an HPLC grade mixture, acetonitrile-0.01M phosphoric acid adjusted to pH 2.3 (1 + 3, by volume).

Results: The separation was performed in 15 min. The calibration curves of the three impurities were linear; the correlation coefficients were 0.999 at concentrations of 0.00015-0.003 µg/mL.

Conclusion: The validation of this method shows that it meets all validation criteria. This shows the reliability of this method for the routine control of diclofenac impurities.

Highlights: The validation of a robust HPLC method for the determination of diclofenac impurities is of great importance for the pharmaceutical industry to control its products.

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凝胶制剂中双氯芬酸二乙胺及其三种杂质的高效液相色谱测定方法的验证。

背景：监测药品中的杂质是世界各地药品监管部门确保药品安全的主要要求。因此，非常需要对羽绒被产品进行分析质量控制。目的：建立一种简便、高效、直接的高效液相色谱法测定双氯芬酸中三种杂质的含量。方法：采用高效液相色谱法，流动相为乙腈-0.01M磷酸，pH调节至2.3（1+3，按体积计） min.三种杂质的校准曲线为线性；浓度为0.00015-0.003时，相关系数为0.999 µg/mL。结论：该方法的验证表明，它符合所有验证标准。这表明该方法用于双氯芬酸杂质的常规控制是可靠的。亮点：高效液相色谱法测定双氯芬酸杂质的验证对制药行业控制其产品具有重要意义。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of AOAC International 医学-分析化学

CiteScore

3.10

自引率

12.50%

发文量

144

审稿时长

2.7 months

期刊介绍： The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.