Abstract
Objective: The objective of the study was to develop and validate reverse-phase high-performance liquid chromatography (RP-HPLC) method and apply method to tablet dosage form.
 Methods: A simple, rapid, economical, precise, and accurate RP-HPLC method for simultaneous estimation of lamivudine and zidovudine in their combined dosage form has been developed.
 Results: A RP-HPLC method was developed for the simultaneous estimation of lamivudine and zidovudine. In their combined dosage form has been developed. The separation was achieved by LC-C18 column (150 mm ×4.6 mm, 5 μm) and water: methanol (65:35v/v) as mobile phase, at a flow rate of 0.8 ml/min. Detection was carried out at 272 nm. Retention time of lamivudine and zidovudine was found to be 3.007 min and 4.647, respectively. The method has been validated for linearity, accuracy, and precision. The assay method was found to be linear from 50% to 150% for lamivudine and zidovudine.
 Conclusion: Developed method was found to be accurate, precise, and rapid for simultaneous estimation of lamivudine and zidovudine in their combined dosage form.
Highlights
Lamivudine designated chemically as 4-Amino-1-[(2R,5S)-2(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one (Fig. 1) is a compound of the pyrimidine class and is used as antiviral agent [1,2]
Reagents and Chemicals Lamivudine and zidovudine were obtained as gift samples from Cipla Pharmaceuticals Ltd., combined dosage form tablet was purchased from local market
Instruments and chromatographic conditions Young Lin high-performance liquid chromatography (HPLC) system was used for method development, degradation studies, and validation
Summary
Lamivudine designated chemically as 4-Amino-1-[(2R,5S)-2(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one (Fig. 1) is a compound of the pyrimidine class and is used as antiviral agent [1,2]. It acts by inhibiting the HIV reverse transcriptase as well as hepatitis B virus. Various analytical methods have been reported for the estimation of lamivudine as alone as well as in combination with other drugs They include thin-layer chromatography (TLC) [3], high-performance liquid chromatography (HPLC) [4], and reverse-phase (RP)-HPLC methods with other drugs [4,5,6]
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