Simultaneous determination of lamivudine and stavudine in antiretroviral fixed dose combinations by first derivative spectrophotometry and high performance liquid chromatography

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 41; no. 3; pp. 761 - 765
• Main Authors: Kapoor, Namita, Khandavilli, Sateesh, Panchagnula, Ramesh
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 07.06.2006; Elsevier Science
• Subjects: Analysis; Analytical, structural and metabolic biochemistry; Biological and medical sciences; Chromatography, High Pressure Liquid - methods; Drug Combinations; First derivative spectroscopy; Fixed dose combinations (FDCs); Fundamental and applied biological sciences. Psychology; General pharmacology; HPLC; Lamivudine (3TC); Lamivudine - analysis; Medical sciences; Pharmacology. Drug treatments; Reference Standards; Reproducibility of Results; Reverse Transcriptase Inhibitors - analysis; Sensitivity and Specificity; Spectrophotometry, Ultraviolet - methods; Stavudine (d4T); Stavudine - analysis; Zero-crossing measurements; Fixed dose combinations (FDCs); Zero-crossing measurements; Stavudine (d4T); Lamivudine (3TC); HPLC; First derivative spectroscopy; Antiretroviral agent; RNA-directed DNA polymerase; Derivative spectrometry; Enzyme; Transferases; Enzyme inhibitor; HPLC chromatography; Lamivudine; Stavudine; Nucleotidyltransferases; Dideoxynucleoside; Reverse transcriptase inhibitor; Simultaneous measurement; Nucleoside analog; Antiviral; Pyrimidine nucleoside; Quantitative analysis
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2006.01.007

Two methods are described for the simultaneous determination of lamivudine (3TC) and stavudine (d4T) in combined pharmaceutical tablets. The first method depends on first derivative UV-spectrophotometry with zero-crossing measurement technique. The first derivative absorbances at 280 and 300 nm were selected for the determination of stavudine and lamivudine, respectively. The second method is based on the separation of both drugs by high performance liquid chromatography using methanol:water (20:80) as the mobile phase at 0.6 ml/min on a reverse phase column with detection at 270 nm. Both the methods showed good linearity, reproducibility and precision. No spectral or chromatographic interferences from the tablet excipients were found. The proposed methods were suitably applied to the assay of commercial formulations. The procedures were rapid, simple and suitable for routine quality control application.