Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR LAMIVUDINE IN COMPARISON TO HPLC METHODS

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. Though several HPLC methods are reported for the estimation of Lamivudine no spectrophotometric methods are available .The objective of the present study is to develop a simple, rapid, accurate, precise UV spectrophotometric method for the estimation of Lamivudine in bulk and in pharmaceutical formulations, which can be considered as a useful alternative to the expensive HPLC methods. The method developed was validated with regard to linearity, precision, accuracy, selectivity, sensitivity, LOD, LOQ robustness, ruggedness, as per ICH guidelines and compared with two HPLC methods reported in the literature. The UV spectrophotometric method developed is based on measurement of absorbance at 280 nm in either water (or) 0.01 M HCl. In both the solvents the max was found at 280nm. The UV absorbance values were not affected by changing pH. Analysis of absorbance measurements indicated that the drug solutions were stable when stored at +4oc and at RT 28 oC for 2 weeks. The method obeyed beer’s law in the concentration range of 1- 10μg/ml in both the solvents. The UV spectrophotometeric method developed is comparable to the HPLC methods with regard to Linearity, LOD, LOQ, accuracy, precision and recovery. In the case of UV spectrophotometeric method linearity was observed in a lower concentration range when compared to HPLC methods. LOD, LOQ, accuracy, precision and recovery parameters are almost similar in both UV spectrophotometeric and HPLC methods. In addition the method developed was sufficiently rugged and robust. The UV spectrophotometeric method developed was simple, rapid and less time consuming and cost effective when compared to HPLC methods for the routine analysis of Lamivudine in quality control testing.

Keywords: Lornoxicam, UV Spectrophotometric method, Validation, HPLC methods.