The present work describes Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Trifluridine and Tipiracilin bulk and their combined dosage form. The chromatographic separation was performed on Column :XterraC 18 (150mm x 4.5mm x 5µ) using Trietylamine buffer: Acetonitrile (40:60) as mobile phase at a flow rate of 1 mL/min and column oven temperature of 30ºC. The detection was carried out using a Diode array detector at 272 nm. Total run time was 10 minutes within which main compounds and their degradation products were separated. The method was validated for accuracy, repeatability, reproducibility, robustness, linearity, limit of detection and quantification were established. The developed method was successfully applied to the simultaneous quantitative analysis of the title drugs in tablet dosage forms.
Background
The aim of this study was to develop and validate accurate and precise UPLC method with tandem mass spectrometry (Waters) for the determination of bexarotene in human plasma using bexarotene D4 as internal standard (IS).
Results
The retention time of bexarotene was 2.75 ± 0.30 min. The method was validated with respect to system suitability, linearity, accuracy, precision, matrix effect, auto sampler carryover test, and recovery. Linearity was found to be 1.04 to 351.93 μg/mL. LOQQC, LQC, INTQC, MQC, and HQC were found to be 1.0550, 2.7800, 25.2700, 131.61, and 263.23 respectively. The mean percentage recovery was found to be 95.72%
Conclusion
The bioanalytical method, a selective and sensitive liquid chromatography-mass spectrometry method to quantitate bexarotene in K2EDTA human plasma over the concentration range 1.0440 to 351.9320 ng/mL, was successfully validated. This method is suitable for sample analysis to support bioequivalence/bioavailability and/or pharmacokinetic studies involving formulations of bexarotene.
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