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DEVELOPMENT AND VALIDATION OF A SENSITIVE LCMS/MS METHOD FOR THE DETERMINATION OF STAVUDINE, LAMIVUDINE AND NEVIRAPINE IN HUMAN PLASMA

Journal Name:

  • The International Journal of Pharmaceutical Research and Bio-Science

Publication Year:

  • 2013

Key Words:

Author Name
Abstract (2. Language): 
A simple and sensitive liquid chromatography tandem mass spectrometry (LCMS/MS) method for the determination of stavudine, lamivudine and nevirapine in human plasma was developed and validated to support the pharmacokinetic studies. Didanosine (for stavudine) and emtricitabine (for lamivudine and nevirapine) are used as internal standards and solid phase extraction was employed as the extraction technique with the sample volume of 300 ul. 2 mM ammonium acetate buffer and methanol in the ratio of 5:95 was used as mobile phase using C18 zorbax eclipse (4.6x150mm, 5u) column for chromatographic separation. ESI/MSMS in the positive mode with the mass transitions (m/z) of 223.00/125.00 for stavudine, 228.10/133.90 for lamivudine, 264.90/181.90 for nevirapine, 234.90/134.90 for didanosine and 245.90/151.90 for emtricitabine were used for detection. The method linearity range was established as 5 to 1500 ng/ml for stavudine, 5 to 2000 ng/ml for lamivudine and 10 to 4000 ng/ml for nevirapine with the weighting factor of 1/X2. The method was validated as per the regulatory guidelines and the results of the method validation were in compliance to the acceptable limits specified by the regulatory guidelines confirming the method readiness for the pharmacokinetic studies.
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