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

被引：1

作者：

El Kacemi, Mounir ^{[1
]}

El Orche, Aimen ^{[2
]}

Elhamdaoui, Omar ^{[1
]}

Laouni, Amine ^{[1
]}

Azougagh, Mohamed ^{[3
]}

Karrouchi, Khalid ^{[1
]}

Bouatia, Mustapha ^{[1
]}

El Karbane, Miloud ^{[1
]}

机构：

[1] Univ Mohammed 5, Fac Med Pharm, Lab Chim Analyt Bromatol, Mpasse Souissi 10100, Rabat, Morocco

[2] Univ Sultan Moulay Slimane, Lab Organ & Analyt Chem, Campus Mghilla,BP 523, Beni Mellal 23000, Morocco

[3] Mohammed V Univ, Natl Grad Sch Arts & Crafts ENSAM, Biomed Engn & Pharmaceut Sci Grp Res, 6207 Av Forces Armees Royales, Rabat 10100, Morocco

来源：

JOURNAL OF AOAC INTERNATIONAL | 2023年 / 106卷 / 06期

关键词：

INDICATING UPLC METHOD; SODIUM; CHLORZOXAZONE; DEGRADATION;

D O I：

10.1093/jaoacint/qsad078

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

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 mu g/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.

引用

页码：1443 / 1454

页数：12

共 23 条

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