A LCMS/MS method was developed and validated for estimation of rivaroxaban in human plasma. A simple LLE method was used for sample preparation. An isocratic method with a flow rate of 1.0ml/min was used to elute the sample from a C8 column and analyzed using positive atmospheric ionization mode in LCMS/MS API 4000. Rivaroxaban D4 was used as an internal standard. The method was linear in the range of 0.5-609.3ng/ml and the lower limit of quantification was 0.5 ng/ml. Assay accuracy and the precision were in the range of 87.5-112.6% and 0.7-10.9%, respectively. Recovery was 69.7%. This method was successfully used in a bioequivalence study.
Aim: ZY-19489 is a new antimalarial drug candidate and selective LC–MS/MS method was established for estimation of ZY-19489 and its metabolite in human plasma. Materials & methods: LLE was employed for extraction, mass spectrometric quantification performed using positive ionization mode and DCP-IMP was used as an internal standard. The chromatographic separation was achieved using mobile phase 5 mM ammonium formate in water and 0.1% v/v ammonia solution in methanol:acetonitrile (90:10% v/v) and column Agilent Zorbex Extended C18, 3.5 μm, 100 × 4.6 mm with a 6-min run time. Results: The calibration curve of ZY-19489 was linear over range 1–500 ng/ml and 2–200 ng/ml for metabolite. Assay was reproducible, selective and devoid of matrix effect. Conclusion: The validated assay was implemented for clinical sample analysis derived from healthy human subjects and parasitemia-induced subjects.
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