Development and Validation of Uv Spectroscopic Method for Estimation of Lamivudine in Tablet Dosage Form

Abstract

Objective: To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Lamivudine in tablet dosage form. Methods:The drug is freely soluble in analytical grade water. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade water. The drug obeyed the Beer's law and showed a good correlation of concentration with absorption which reflects in linearity. The UV spectroscopic method was developed for estimation of lamivudine in tablet dosage form and also validated as per ICH guidelines. Results:The drug is freely soluble in analytical grade water, slightly soluble in methanol and practically insoluble in acetone. So, the analytical grade water is used as a diluent in the method. The melting point of lamivudine was found to be 160-161˚C (uncorrected). It showed absorption maxima 268 nm in analytical grade water. On the basis of the absorption spectrum, the working concentration was set on 10µg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of the analysis were validated by recovery studies. The recovery was found to be 98.7, 101 and 99.2% for three levels respectively. The % RSD for precision was found to be 0.62%. Conclusion:A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Lamivudine in tablet dosage form. The method could be considered for the determination of Lamivudine in quality control laboratories.

Rp-HPLC (Stability-Indicating) Based Assay Method for the Simultaneous Estimation of Doravirine, Tenofovir Disoproxil Fumarate and Lamivudine

“…The flow rate remains constant all along the trails at 1.0 ml per min. During trails, the results were checked for values of tailing factor, peak areas, theoretical plates and resolution for the The method presented was selective for the combined assay of LMV, TFF and DRV in tablets without interruption with diluent solvent system components and tablet excipients [14][15][16][17][18][19][20][21][22][23][24][25][26][27]29,30]. The coefficients of regression higher than 0.99 indicating a lined correlation between the LMV, TFF, and DRV concentration and their respective area responses [14][15][16][17][18][19][20][21][22][23][24][25][26][27]29,30].…”

“…During trails, the results were checked for values of tailing factor, peak areas, theoretical plates and resolution for the The method presented was selective for the combined assay of LMV, TFF and DRV in tablets without interruption with diluent solvent system components and tablet excipients [14][15][16][17][18][19][20][21][22][23][24][25][26][27]29,30]. The coefficients of regression higher than 0.99 indicating a lined correlation between the LMV, TFF, and DRV concentration and their respective area responses [14][15][16][17][18][19][20][21][22][23][24][25][26][27]29,30]. The method was sufficiently sensitive for the combined assay of LMV, TFF and DRV in tablets because of low values of quantification and detection limits [14][15][16][17][18][19][20][21][22][23][24][25][26][27...…”

“…The precision results were below 2% RSD. The reports indicated that the assay method was precise for the LMV, TFF and DRV combined analysis [14][15][16][17][18][19][20][21][22][23][24][25][26][27]29,30]. The robustness results were below 2% RSD.…”

“…To quantify LMV, spectrophotometry [14,15] and HPLC [16][17][18][19] based methods were proposed. TFF was quantified using spectrophotometry [20], HPLC [21][22][23][24] and LC-MS [25,26] based methods.…”