ISSN: 2376-0419
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Prasenjit Mondal1, Satla Sobha Rani2 and Raparla Ramakrishna3
Posters-Accepted Abstracts: J Pharma Care Health Sys
In the present study an effective high performance liquid chromatography-tandem mass spectrophotometric (LCMS/MS) method was developed and validated for the simultaneous quantification of Escitalopram (ESC) and Etizolam (ETZ) in spiked human plasma. This is the first reporting method for this combination in human plasma. Risperidone is used as internal standard. Liquidliquid extraction (LLE) method was adopted for the extraction of analytes from human plasma. Chromatographic separation was attained on a waters symmetry shield, C18 (4.6 mm id x 50 mm) analytical column using acetonitrile-solvent A 1% formic acidsolvent B (80:20, v/v) with a flow rate of 600 μl/min. The MS/MS experiment was performed in positive ion multiple reactions monitoring (MRM) to obtain the product ion m/z 325.15â??108.99 for ESC, m/z 343.2â??138.1 for ETZ and m/z 411.40â?? 191.30 for internal standard. The obtained calibration curve was linear over the range of 5 â?? 2000 ng/ml for both the analytes with r2 value more than 0.98 for both analytes. The developed method was shown excellent intra and inerday accuracy (% nominal 98 â?? 102%), precision (% CV â?¤4.5%), matrix effect (Is normalized matrix factor â?¤ 8.55), selectivity (% interference = 0) with an acceptable extraction recovery (92.75% - 98.80%) and stability (% nominal 98.40 â?? 101.4%) of different types. Method validation was performed as per US FDA guidelines for bioanalytical method development and validation and undoubtedly this first reporting bioanalytical method can be use for the pharmacokinetic, bioavailability and bioequivalence studies.