Validated green and white RP-HPLC method for the estimation of Zolmitriptan in marketed dosage form.

IF 1 Q4 PHARMACOLOGY & PHARMACY Annales pharmaceutiques francaises Pub Date : 2024-08-31 DOI:10.1016/j.pharma.2024.08.010

Channabasavaiah Naveenaradhya, Veeresh Prabhakar Veerapur, Ranganatha Puttaraju, Kodigenahalli Balarajagupta Ajaykumar, DeviReddy Prashanthi, Varsha D Savanth, Mathud Shivamurthaiah Chaithanya, Bychapur Siddaiah Gowrishankar

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Abstract

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.

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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。

材料和方法： - 采用 Luna (C18) (4.6 x 250 mm, 5 µm)色谱柱和磷酸钠缓冲液（pH 4.7），以甲醇[75:25, v/v]为流动相，流速为 1.0 mL/min：流动相为甲醇[75: 25, v/v]，流速为 1.0 mL/min。检测波长为 227 纳米。此外，还通过绿色和白色工具对优化分析方法的环保性、生产率和性能进行了评估：- 佐米曲普坦的保留时间为 3.25 分钟，色谱参数可接受。经AES、AGREE、GAPI和RGB工具确认，优化后的RP-HPLC方法比已报道的方法更环保、高效、通量大且实用。此外，该分析方法的所有验证参数均在 ICH Q2 R1 指南的接受范围内。线性回归分析表明，在 10 至 120 μg/mL 浓度范围内线性响应良好，R2 为 0.99998。佐米格-5 毫克片剂中佐米曲普坦的含量百分比和测定百分比分别为 103.36 ± 0.356 % 和 97.86 ± 0.693 %。

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来源期刊

Annales pharmaceutiques francaises PHARMACOLOGY & PHARMACY-

CiteScore

1.70

自引率

7.70%

发文量

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.