HPLC method development and validation for simultaneous determination of lamivudine and tenofovir in tablet dosage

Authors

  • Vishnumanikandan N
  • Shine Sudev
  • Najuma Salim
  • Ajmal Shareef K
  • Sapna Shrikumar

Keywords:

Lamivudine, Tenofovir, Method development, RP-HPLC, Validation

Abstract

A simple, reverse-phase high performance liquid chromatographic method has been developed and validated for the
simultaneous estimation of Lamivudine and Tenofovir disoproxil fumarate in pure and tablet dosage form. The
chromatographic Separation was carried out using on Hypersil BDS C18 column (250 x4.6mm id, 5 particle size) in
isocratic mode with flow rate of 1mLmin-1 and the detection was carried out by photo diode array detector at 260nm. The
mobile phase consists of 0.01N Sodium Dihydrogen Ortho Phosphate Buffer (pH 4.5±0.5) and acetonitrile in the ratio of
50:50 (v/v). The retention time for Lamivudine and Tenofovir was found to be 2.18mins and 3.64mins respectively. The
linearity was obtained in the concentration range of 75- 450µgmL-1 for both the Lamivudine and Tenofovir Disoproxil
Fumarate. The LOD was found 0.92µgmL-1 and 2.37µgmL-1 for Lamivudine and Tenofovir respectively, whereas LOQ
was found to be 2.79µgmL-1 for Lamivudine and 7.17µgmL-1 for Tenofovir. The percentage recovery was found to be
99.84 – 100.54 for Lamivudine and 99.72 – 100.82 for Tenofovir respectively. The method was statistically validated as
per ICH guidelines and %RSD was found to be less than 2 indicating high degree of accuracy and precision of the
proposed HPLC method.

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Published

2015-07-03