تعیین کمی کلاولانیک اسید در پلاسمای انسان توسط کروماتوگرافی مایع- اسپکترومتری جرمی متوالی و کاربرد آن در مطالعه سینتیک دارو
Publish place: Iranian Journal of Analytical Chemistry، Vol: 4، Issue: 2
Publish Year: 1396
نوع سند: مقاله ژورنالی
زبان: English
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شناسه ملی سند علمی:
JR_IJAC-4-2_005
تاریخ نمایه سازی: 22 تیر 1398
Abstract:
A rapid, selective and sensitive liquid chromatography–tandem mass spectrometry (LC–MS/MS) assay has been proposed for the determination of Clavulanic acid (CA) in human plasma using Diclofenac sodium as internal standard (IS). The analyte and IS were extracted from human plasma via solid phase extraction and the chromatographic separation was achieved on Inertsil ODS-3, 50 x 4.6 mm, 5µ column under isocratic conditions. Detection of CA and IS was done by tandem mass spectrometry, operating in positive ionization and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for CA and IS were m/z 365.2→240.2 and 409.2→228.2, respectively. The method was fully validated as per the US FDA guidelines. The linear dynamic range of CA was 7.564 - 897.893 ng/mL. The intra-batch and inter-batch precision (%CV) was ≤ 14.1% while the mean extraction recovery was 84.48 % across quality control levels. It was successfully applied to a bioequivalence study of Cefdinir/CA (125 mg/62.5 mg) suspension formulation in 32 healthy Indian male subjects under fasting condition.
Keywords:
Clavulanic Acid , Liquid Chromatography–Tandem Mass Spectrometry , Human Plasma , solid phase extraction , Pharmacokinetics Study
Authors
Milan Modi
Pharmazone Research Partner, S.G. Highway, Ahmedabad, India
Punit Parejiya
K. B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwavidyalaya, Gandhinagar, India
Nikunj Patel
K. B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwavidyalaya, Gandhinagar, India
Rakesh Sutariya
Pharmazone Research Partner, S.G. Highway, Ahmedabad, India
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