Development of a new rapid, economical and eco-friendly HPLC method for in vitro and in vivo determination of zolmitriptan

被引:0
|
作者
Shah, Kiramat Ali [1 ]
Gao, Binbin [2 ]
Zhu, Qiu Ning [1 ]
Kamal, Robia [1 ]
Razzaq, Anam [1 ]
Lina, Song [1 ]
Huang, Linyu [1 ]
Iqbal, Haroon [3 ]
Khan, Naveed Ullah [4 ]
Cui, Jing-Hao [1 ]
机构
[1] Soochow Univ, Coll Pharmaceut Sci, Suzhou, Peoples R China
[2] Royal Coll Surg Ireland RCSI, Dublin, Ireland
[3] Univ Chinese Acad Sci, Chinese Acad Sci, Inst Basic Med & Canc IBMC, Canc Hosp,Zhejiang Caner Hosp, Hangzhou, Zhejiang, Peoples R China
[4] Univ Chenab, Gujrat, Punjab, Pakistan
关键词
ICH and USFDA guidelines; method development and validation; zolmitriptan; rizatriptan; RP-HPLC; HUMAN PLASMA; LIQUID;
D O I
10.36721/PJPS.2022.35.6.REG.1637-1646.1
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Multiple high-perfo lance liquid chromatographic (HPLC) approaches have been briefly defined for the assessment of zolmitriptan (ZMT). These methods are either cumbersome or require a plentiful volume of organic solvents, thus offering extortionate procedures. The objective of this study was to establish and validate a new rapid, ecofriendly and cost-effective HPLC method for the analysis of ZMT. The calibration curve for ZMT was established using simulated salivary fluid (SSF) and rat plasma for in-vitro and in-vivo analysis, respectively. Chromatogram separation was perfouned using a CST column (250mm x 4.6mm, 5 mu m) as a stationary phase and maintained at a temperature of 40 degrees C. The methods were authenticated for linearity, system suitability, accuracy, precision, reproducibility, limit of detection (LOD) and limit of quantification (LOQ). The results of the validation variables and stability studies indicated that the methods were established in accordance with the guidelines of ICH and the USFDA. The established technique was time-saving, precise, eco- friendly and economical compared with the reported technique. In addition, the developed method was sufficiently repeatable for in vitro and in vivo analysis of ZMT.
引用
收藏
页码:1637 / 1646
页数:10
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