{"title":"经验证的绿色和白色 RP-HPLC 法,用于估算市售剂型中的佐米曲普坦。","authors":"Channabasavaiah Naveenaradhya, Veeresh Prabhakar Veerapur, Ranganatha Puttaraju, Kodigenahalli Balarajagupta Ajaykumar, DeviReddy Prashanthi, Varsha D Savanth, Mathud Shivamurthaiah Chaithanya, Bychapur Siddaiah Gowrishankar","doi":"10.1016/j.pharma.2024.08.010","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To develop and validate a rapid, accurate, economical, effective and greenery RP-HPLC method for the determination of Zolmitriptan in tablet dosage form.</p><p><strong>Material and method: </strong>RP-HPLC method was developed using Luna (C<sub>18</sub>) (4.6×250mm, 5μm) column and Sodium phosphate buffer (pH 4.7): Methanol [75: 25, v/v] was used as mobile phase at a flow rate of 1.0mL/min. The detection was carried out at 227nm. Further, eco-friendliness, productivity and performance of the optimized analytical method were assessed by green and white tools.</p><p><strong>Results: </strong>The retention time of Zolmitriptan was found to be 3.25min with acceptable chromatographic parameters. The optimized RP-HPLC method was more eco-friendly, efficient, throughput and practicable than the reported methods as confirmed by AES, AGREE, GAPI and RGB tools. Further, the proposed analytical method showed all the validation parameters within the acceptance limit of ICH Q<sub>2</sub> R<sub>1</sub> guidelines. The linear regression analysis indicated a good linear response in the 10 to 120μg/mL concentration range with R<sup>2</sup> of 0.99998. The percentage content and percentage assay of Zolmitriptan in Zomig-5mg tablet was found to be 103.36±0.356% and 97.86±0.693%.</p><p><strong>Conclusion: </strong>The developed and validated method has several advantages compared to the reported HPLC methods and is useful in the systematic analysis of Zolmitriptan in its dosage form.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0000,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validated green and white RP-HPLC method for the estimation of Zolmitriptan in marketed dosage form.\",\"authors\":\"Channabasavaiah Naveenaradhya, Veeresh Prabhakar Veerapur, Ranganatha Puttaraju, Kodigenahalli Balarajagupta Ajaykumar, DeviReddy Prashanthi, Varsha D Savanth, Mathud Shivamurthaiah Chaithanya, Bychapur Siddaiah Gowrishankar\",\"doi\":\"10.1016/j.pharma.2024.08.010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To develop and validate a rapid, accurate, economical, effective and greenery RP-HPLC method for the determination of Zolmitriptan in tablet dosage form.</p><p><strong>Material and method: </strong>RP-HPLC method was developed using Luna (C<sub>18</sub>) (4.6×250mm, 5μm) column and Sodium phosphate buffer (pH 4.7): Methanol [75: 25, v/v] was used as mobile phase at a flow rate of 1.0mL/min. The detection was carried out at 227nm. Further, eco-friendliness, productivity and performance of the optimized analytical method were assessed by green and white tools.</p><p><strong>Results: </strong>The retention time of Zolmitriptan was found to be 3.25min with acceptable chromatographic parameters. The optimized RP-HPLC method was more eco-friendly, efficient, throughput and practicable than the reported methods as confirmed by AES, AGREE, GAPI and RGB tools. Further, the proposed analytical method showed all the validation parameters within the acceptance limit of ICH Q<sub>2</sub> R<sub>1</sub> guidelines. The linear regression analysis indicated a good linear response in the 10 to 120μg/mL concentration range with R<sup>2</sup> of 0.99998. The percentage content and percentage assay of Zolmitriptan in Zomig-5mg tablet was found to be 103.36±0.356% and 97.86±0.693%.</p><p><strong>Conclusion: </strong>The developed and validated method has several advantages compared to the reported HPLC methods and is useful in the systematic analysis of Zolmitriptan in its dosage form.</p>\",\"PeriodicalId\":8332,\"journal\":{\"name\":\"Annales pharmaceutiques francaises\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2024-08-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annales pharmaceutiques francaises\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/j.pharma.2024.08.010\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annales pharmaceutiques francaises","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.pharma.2024.08.010","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Validated green and white RP-HPLC method for the estimation of Zolmitriptan in marketed dosage form.
Objective: To develop and validate a rapid, accurate, economical, effective and greenery RP-HPLC method for the determination of Zolmitriptan in tablet dosage form.
Material and method: RP-HPLC method was developed using Luna (C18) (4.6×250mm, 5μm) column and Sodium phosphate buffer (pH 4.7): Methanol [75: 25, v/v] was used as mobile phase at a flow rate of 1.0mL/min. The detection was carried out at 227nm. Further, eco-friendliness, productivity and performance of the optimized analytical method were assessed by green and white tools.
Results: The retention time of Zolmitriptan was found to be 3.25min with acceptable chromatographic parameters. The optimized RP-HPLC method was more eco-friendly, efficient, throughput and practicable than the reported methods as confirmed by AES, AGREE, GAPI and RGB tools. Further, the proposed analytical method showed all the validation parameters within the acceptance limit of ICH Q2 R1 guidelines. The linear regression analysis indicated a good linear response in the 10 to 120μg/mL concentration range with R2 of 0.99998. The percentage content and percentage assay of Zolmitriptan in Zomig-5mg tablet was found to be 103.36±0.356% and 97.86±0.693%.
Conclusion: The developed and validated method has several advantages compared to the reported HPLC methods and is useful in the systematic analysis of Zolmitriptan in its dosage form.
期刊介绍:
This journal proposes a scientific information validated and indexed to be informed about the last research works in all the domains interesting the pharmacy. The original works, general reviews, the focusing, the brief notes, subjected by the best academics and the professionals, propose a synthetic approach of the last progress accomplished in the concerned sectors. The thematic Sessions and the – life of the Academy – resume the communications which, presented in front of the national Academy of pharmacy, are in the heart of the current events.