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Determination of Camylofin Dihydrochloride and Nimesulide in Pharmaceutical Preparation by Gas Chromatography

American Journal of Analytical Chemistry 2011年第8期2卷 944-952页

作者： Rajeev.Kumar R. Singh manapragada v. rathnam Sangeeta J. Singh Raju v. K. v.gesna 不详

This research paper describes simple analytical method for determination of Camylofin dihydrochloride and Nimesulide in tablet formulation by Gas chromatography method. Benzoic acid was used as internal standard. v.lidation was carried out in compliance with the International Conference on Harmonization guidelines. The method utilized GC (Agilent Technologies 6890 N Network GC system with FID detector), and RTX-5 capillary column (5% diphenyl-95% dimethyl polysiloxane), 30 m × 0.53 mm, 1.5 μm as stationary phase. Helium was used as the carrier gas at a flow rate of 1.5 mL?min–1. The proposed method was v.lidated for linearity, LOD, LOQ, accuracy, precision, ruggedness and solution stability. It can be conv.niently adopted for routine quality control analysis.

关键词： Capillary Column Gas Chromatography Pharmaceutical Preparations Camylofin Dihydrochloride Nimesulide

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Sensitiv. and rapid determination of amantadine without deriv.tization in human plasma by LC–MS/MS for a bioequiv.lence study

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Journal of Pharmaceutical Analysis 2018年第3期8卷 202-207页

作者： Abhaysingh Bhadoriya Shiv.rakash rathnam Bhav.sh DasANDi Dharmesh Parmar Mallika Sanyal Pranav.S.Shriv.stav Bioanalytical Department Synchron Research Services Pvt.Ltd Department of Chemistry St.Xavier's College Department of Chemistry School of Sciences Gujarat University

A highly sensitiv., rapid and rugged liquid chromatography-tandem mass spectrometw （LC-ESI-MS/MS） method was dev.loped for reliable estimation of amantadine （AMD）, an antiv.ral drug in human plasma. The analyte and internal standard （IS）, amantadine-d6 （AMD-d6）, were extracted from 200μL plasma by solid phase extraction on Phenomenex Strata-X-C 33 ~t cartridges. Chromatography was performed on Synergi^TM Hydro-RP C18 （150 mm×4.6 mm, 4 μm） analytical column using a mixture of acetonitrile and 10 mM ammonium formate, pH 3.0 （80：20, v.v. as the mobile phase. Detection and quantitation was done by multiple reaction monitoring in the positiv. ionization mode for AMD （m/z 152.1→ 135.1 ） and IS （m/z 158.0 → 141.1） on a triple quadrupole mass spectrometer. The assay was linear in the concentration range of 0.50-500 ng/mL with correlation coefficient （r^2）〉 0.9969. The limit of detection of the method was 0.18 ng/mL The intra-batch and inter-batch precisions were 〈 5.42% and the accuracy v.ried from 98.47% to 105.72%. The extraction recov.ry of amantadine was precise and quantitativ. in the range of 97.89%-100.28%. IS-normalized matrix factors for amantadine v.ried from 0.981 to 1.012. The stability of AMD in whole blood and plasma was ev.luated under different conditions. The dev.loped method was successfully applied for a bioequiv.lence study with 100 mg of AMD in 32 healthy v.lunteers. The reproducibility of the assay was determined by reanalysis of 134 subject samples.

关键词： Amantadine Amantadine-d6 LC-ESI-MS/MS Sensitiv. Bioequiv.lence study Human plasma

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