Design of dissolution media for in-vitro bioequivalence testing of Lamivudine.

ABSTRACT

The present investigation is aimed at developing the stability indicating dissolution media for the determination of lamivudine (3TC) in pharmaceutical dosage forms. The stability of 3TC was tested in various dissolution media maintained at ambient temperature and 37 oC for 48 hrs. Stability studies of 3TC in various media indicated that the drug was stable in 0.1M HCl, pH 1.2 KCl-HCl buffer, pH 6.2 and pH 7.0 phosphate buffers. The λmax were found to be 280.0, 278.8, 273.0 and 271.5nm for 0.1M HCl, pH 1.2 KCl-HCl buffer, pH 6.2 and pH 7.0 phosphate buffers respectively with low CV of <4.44%. The linearity of standard plots in optimized media was 0.5-40 μg/ml for 0.1M HCl and pH 1.2 KCl-HCl buffer. Similarly it was 0.5-60 μg/ml in pH 6.2 buffer and 0.2-40 μg/ml in pH 7.0 phosphate buffer. The validated methods were applied to determine 3TC concentration in formulations. In-vitro dissolution testing indicated that the 3TC was stable and drug release is uniform from tablet dosage forms. The optimized media could be employed to study the dissolution profiles of 3TC in bioequivalence studies.