Abstract

DETERMINATION OF OXACEPROL (FED AND FASTING PERIOD) BY VALIDATED LC-MS/MS METHOD IN INDIAN HEALTHY HUMAN PLASMA AND ITS APPLICATION TO IN-VIVO COMPARATIVE PHARMACOKINETIC STUDY

Pallab Mandal, Tapan Kumar Pal*, Soumya Chakraborty, Rakesh Bera, Chiranjit Saha and Sanmoy Karmakar

.

Abstract

Aim and Objectives: The main aim of this study is to develop an LCMS/ MS method for quantifying a protein drug oxaceprol from human plasma. Methods: The human plasma and plasma extracted by protein precipitation technique. Oxaceprol was ionized at negative mode and m/z of oxaceprol was 171.9/130 and the internal standard was 269.0/170.0. The calibration concentrations were 62.5 to 8000ng/ml. This bio-analytical method which were successfully applied to comparative pharmacokinetic study and calculated Cmax, Tmax, T1/2, AUC 0-t, AUC 0-α, Kel, and secondary pharmacokinetic parameters like AUMC (ng.hr2./ml), MRT (hr.), Cl/F (ml/hr.), Vz/F (ml), Cmax/D(ng/ml/mg), AUC0-t/D (ng.hr./ml/mg), AUC0-infy/D(ng.hr./ml/mg) of test and reference preparation at fasting and fed condition. Result: After administration of the reference, preparation produced the maximum plasma concentration of 2905.51± 824.53 ng/ml (Cmax) at the time 2.21 ± 0.72 hr (Tmax) and 1169.39± 324.52 ng/ml (Cmax) at the time 2.19 ± 0.62 hr (Tmax) whereas after administration of the test preparation, as a single dose produced the maximum plasma concentration 2785.66 ± 734.73 ng /ml (Cmax) at the time 2.15 ± 0.65 hr (Tmax) and 1201.15 ± 340.83 ng /ml (Cmax) at the time 2.19 ± 0.62hr (Tmax) in fasting and fed state respectively. Conclusion: This is selective, sensitive, specific, reproducible, low ionization suppression, high recovery bio-analytical method which was successfully applied to a comparative pharmacokinetic study.

Keywords: Oxaceprol, BA/BE study, Osteoarthritis, Anti-inflammatory drug, LC-MS/MS, Anti rheumatism.