DEVELOPMENT AND VALIDATION OF A LC-MS/MS BIOANALYTICAL METHOD FOR AZILSARTAN: APPLICATION TO PHARMACOKINETIC STUDIES Authors: Sandhya Rani G , SHYAMALA D, SANDHYA P, SANGEETHA ROY G AND ROJA G
ABSTRACT
A simple, accurate liquid chromatography with tandem mass spectrometry (LC/MS-MS)
method has been developed and validated in human plasma. The method employed liquid-liquid
extraction. Samples containing Azilsartan were chromatographed on a Hypersil gold column
(C18, 5?m, 100 x 4.6 mm) at a temperature of 40°C. The isocratic mobile phase composition
was a mixture of 2 mM ammonium formate (pH 4.0) / methanol (20:80 v/v), which was pumped
at a flow rate of 0.5 mL / min with split ratio of 20:80. The retention time under these
chromatographic conditions was found to be 2.20 minutes with run time 2.82 minute. Ethyl
acetate & n-Hexane (80:20, v/v) was found to be good extracting and produced a satisfactory
chromatogram. The developed LC/MS-MS method was found to be selective, simple, sensitive,
accurate and linear for the analysis of Azilsartan in human plasma. The retention time and inturn
run time was very short, hence required less mobile phase for the method, making it more
economical and rapid. The method was applicable for the pharmacokinetic study of Azilsartan.
Key words: Azilsartan, LC/MS-MS, Validation, Plasma Publication date: 01/03/21 https://ijbpas.com/pdf/2021/March/MS_IJBPAS_2021_5409.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2021/10.3.5409