Annales pharmaceutiques francaises · 2024
Validated green and white RP-HPLC method for the estimation of Zolmitriptan in marketed dosage form.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Naveenaradhya Channabasavaiah, Veerapur Veeresh Prabhakar, Puttaraju Ranganatha, Ajaykumar Kodigenahalli Balarajagupta, Prashanthi DeviReddy, Savanth Varsha D, Chaithanya Mathud Shivamurthaiah, Gowrishankar Bychapur Siddaiah
Аннотация
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.
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.