Development and validation of lc ms ms methods for pharmacokinetic evaluation of ergocalciferol calcitriol and phytonadione in human plasma

Abstract

Various methods were developed on vitamins or their analogs which are used for vitamin deficiency. Some analytical methods were developed in combination dosage forms but these methods were having lengthy sample processing activities whereas some methods were having longer run time which reduces the throughput of analytical labs and some reported methods were having longer run time also. The purpose of present research work was to develop and validate new LC-MS/MS methods either single or simultaneous for the determination of Vitamins like, Calcitriol, Ergocalciferol and Phytonadione with high selectivity and sensitivity in lesser run time. For these methods, various extraction procedures were used including Liquid-liquid extraction, Solid phase extraction. While liquid chromatography was used to separate various analytes and detection was performed through tandem mass spectroscopy. Three Bioanalytical methods were developed with high selectivity and sensitivity. These methods were having short run time. These methods were fully validated by following USFDA guidelines on Bioanalytical Method Validation. Application of these newly developed and validated methods were done on subject sample analysis successfully. newline newline