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.
机构:
Imam Mohammad Ibn Saud Islamic Univ IMSIU, Coll Sci, Dept Chem, Riyadh 11432, Saudi ArabiaImam Mohammad Ibn Saud Islamic Univ IMSIU, Coll Sci, Dept Chem, Riyadh 11432, Saudi Arabia
机构:
Sethupathi Govt Arts Coll, Dept Marine Biol, Ramanathapuram 623502, Tamil Nadu, IndiaSethupathi Govt Arts Coll, Dept Marine Biol, Ramanathapuram 623502, Tamil Nadu, India
Elangovan, Manickam
Anantharaman, Perumal
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机构:
Annamalai Univ, Fac Marine Sci, CAS Marine Biol, Parangipettai 608502, Tamil Nadu, IndiaSethupathi Govt Arts Coll, Dept Marine Biol, Ramanathapuram 623502, Tamil Nadu, India
Anantharaman, Perumal
Kavisri, M.
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机构:
SIMATS Deemed Univ, Saveetha Sch Engn, Dept Infrastrcut Engn, Chennai 602105, Tamil Nadu, IndiaSethupathi Govt Arts Coll, Dept Marine Biol, Ramanathapuram 623502, Tamil Nadu, India
机构:
Univ Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USAUniv Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USA
Zhou, Si
Zuo, Ruixiao
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h-index: 0
机构:
Univ Michigan, Dept Chem, Ann Arbor, MI 48109 USAUniv Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USA
Zuo, Ruixiao
Zhu, Zhuo
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h-index: 0
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Univ Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USAUniv Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USA
Zhu, Zhuo
Wu, Di
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Univ Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USAUniv Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USA
Wu, Di
Vasa, Kruti
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Univ Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USAUniv Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USA
Vasa, Kruti
Deng, Yiwei
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Univ Michigan, Dept Nat Sci, Dearborn, MI 48128 USAUniv Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USA
Deng, Yiwei
Zuo, Yuegang
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机构:
Univ Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USAUniv Massachusetts Dartmouth, Dept Chem & Biochem, N Dartmouth, MA 02747 USA
机构:
Prince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi ArabiaPrince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia
Alqarni, Mohammed H.
Shakeel, Faiyaz
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机构:
King Saud Univ, Coll Pharm, Dept Pharmaceut, Riyadh 11451, Saudi ArabiaPrince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia
Shakeel, Faiyaz
Foudah, Ahmed I.
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Prince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi ArabiaPrince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia
Foudah, Ahmed I.
Aljarba, Tariq M.
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Prince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi ArabiaPrince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia
Aljarba, Tariq M.
Mahdi, Wael A.
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King Saud Univ, Coll Pharm, Dept Pharmaceut, Riyadh 11451, Saudi ArabiaPrince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia
Mahdi, Wael A.
Bar, Fatma M. Abdel
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机构:
Prince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia
Mansoura Univ, Fac Pharm, Dept Pharmacognosy, Mansoura 35516, EgyptPrince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia
Bar, Fatma M. Abdel
Alshehri, Sultan
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机构:
AlMaarefa Univ, Coll Pharm, Dept Pharmaceut Sci, Ad Diriyah 13713, Saudi ArabiaPrince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia
Alshehri, Sultan
Alam, Prawez
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机构:
Prince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi ArabiaPrince Sattam Bin Abdulaziz Univ, Coll Pharm, Dept Pharmacognosy, Al Kharj 11942, Saudi Arabia