Abstract

FORMULATION DEVELOPMENT OF LAMIVUDINE TABLETS - APPLICATION OF A NEW UV SPECTROPHOTOMETRIC METHOD DEVELOPED

K. P. R. Chowdary*, K. Ravi Shankar and Prathyusha. Ravi

ABSTRACT

Lamivudine is a potent nucleoside analog reverse transcriptase inhibitor (nRTI) used as an antiretroviral drug. A new UV spectrophotometric method comparable to HPLC methods is developed for lamivudine and reported earlier. The objective of the present study is to evaluate the UV spectrophotometric method developed for lamivudine for its application in formulation development studies. Lamivudine tablets were formulated employing commonly used tablet excipients. The effect of two diluents and two disintegrants on the disintegration and dissolution rate of Lamivudine tablets was evaluated. The tablets were prepared by wet granulation method and evaluated for hardness, friability, drug content, disintegration time and dissolution rate characteristics. The drug content and dissolution rate of drug from the prepared tablets was determined by the UV spectrophotometric method developed. For comparison the dissolution rate of one market brand of Lamivudine tablets was also studied. All the tablets prepared fulfilled the official (IP2010) specifications of hardness, friability, drug content and disintegration time of uncoated tablets. All the dissolution parameters estimated (PD10, DE30, and K1) indicated rapid dissolution of Lamivudine from all the tablets formulated. Tablets formulated employing lactose as diluent (F1, F2) gave rapid and higher dissolution of Lamivudine when compared to those formulated employing DCP as diluent(F3, F4). With both the diluents, tablets formulated employing Primojel as disintegrant gave higher dissolution rate of Lamivudine than those formulated with potato starch as disintegrant. The market brand also gave rapid dissolution of Lamivudine. Among all, formulation F1 prepared using lactose as diluent and Primojel as disintegrant gave rapid and higher dissolution of Lamivudine when compared to all other formulations and also market brand. Hence lactose as diluent and Primojel as disintegrant are recommended for the formulation of Lamivudine tablets with fast dissolution characteristics. Thus the UV spectrophotometric method developed could be applied in the formulation development research to evaluate the products formulated and to select the best.

Keywords: Lamivudine, UV Spectrophotometric method, Formulation development.