Mounir El Kacemi, Aimen El Orche, Omar Elhamdaoui, Amine Laouni, Mohamed Azougagh, Khalid Karrouchi, Mustapha Bouatia, Miloud El Karbane
{"title":"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。","authors":"Mounir El Kacemi, Aimen El Orche, Omar Elhamdaoui, Amine Laouni, Mohamed Azougagh, Khalid Karrouchi, Mustapha Bouatia, Miloud El Karbane","doi":"10.1093/jaoacint/qsad078","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>In this study, a simple, efficient, and direct HPLC method was developed for the determination of three impurities of diclofenac.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Highlights: </strong>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.</p>","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validation of an HPLC Method for the Determination of Diclofenac Diethylamine and Three of Its Impurities in a Gel Pharmaceutical Form.\",\"authors\":\"Mounir El Kacemi, Aimen El Orche, Omar Elhamdaoui, Amine Laouni, Mohamed Azougagh, Khalid Karrouchi, Mustapha Bouatia, Miloud El Karbane\",\"doi\":\"10.1093/jaoacint/qsad078\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>In this study, a simple, efficient, and direct HPLC method was developed for the determination of three impurities of diclofenac.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Highlights: </strong>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.</p>\",\"PeriodicalId\":15003,\"journal\":{\"name\":\"Journal of AOAC International\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2023-11-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of AOAC International\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"https://doi.org/10.1093/jaoacint/qsad078\",\"RegionNum\":4,\"RegionCategory\":\"农林科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of AOAC International","FirstCategoryId":"97","ListUrlMain":"https://doi.org/10.1093/jaoacint/qsad078","RegionNum":4,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
Validation of an HPLC Method for the Determination of Diclofenac Diethylamine and Three of Its Impurities in a Gel Pharmaceutical Form.
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.
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.
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