|
Development and validation of a sensitive bioanalytical method for the estimation of anti-viral drugs by lc-ms/ms method
|
|
| Author:
|
, D.AKILADEVI, MOUNIKA V
|
| Abstract:
|
A rapid, precise, accurate, specific & simple liquid chromatography-tandem mass spectrometry (LC-MS/MS)
method was developed for the quantification of anti-viral drugs like lamivudine, tenofovir & efavirenz in human
plasma. Chromatographic separation was done on Xterra, C18 (2), 150 X 4.6 mm, 5 µm column with a mobile
phase composed of 10mM ammonium formate-methanol-acetonitrile in the ratio of 50:25:25 (v/v/v), at a flow
rate of 1.0 mL/min . Turbo ion-spray interface (TIS) operated in positive ionization mode was used for the
mass spectrometric detection. The MRM transitions monitored were m/z 230.1/112.1 (lamivudine), m/z
288.0/176.2 (tenofovir),m/z 316.2/168.1 (Efavirenz), m/z 248.1/130.1 (Emtricitabine,ISTD) and m/z
287.2/191.2(Abacavir,ISTD). The method was developed and the established calibration ranges are 10-3018
ng/mL, 5-500ng/mL and 20-6021ng/mLfor lamivudine, tenofovir disoproxilfumarateand efavirenz respectively.
The slope values are consistent and regression values were found to be more than or equal to 0.99. The
accuracy for run size reproducibility batch and dilution integrity (1/2, 1/4) for lamivudine,
tenofovir disoproxilfumarateand efavirenz was found to be in the range of 96.9-102.2%. The precision was
found to be less than 8.1% for three analytes. Further, the reported method was validated as per the ICH
guidelines and found to be well with in the acceptable range.
|
| Keyword:
|
Lamivudine, Tenofovir, Efavirenz, Abacavir and Emtricitabine
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2021.13.03.36
|
| Download:
|
Request For Article
|
|
|