DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF LAMIVUDINE IN TABLET DOSAGE FORM
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 Beerâ€™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 160-161ËšC (uncorrected). It showed absorption maxima 268 nm in analytical grade water. On the basis of the absorption spectrum, the working concentration was set on 10Âµg/ml (PPM). The linearity was observed between 6-14 Î¼g/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.
2. https://www.drugbank.ca/drugs/DB00709. [Last accessed on 26 Aug 2017]
3. Tripahti KD. Essential of medical pharmacology. 6th Edn. Jaypee Brother Medical publisher, New Delhi; 2003. p. 809-11, 815, 816.
4. Satoskar RS, Rage NN. Pharmacology and pharmacotherapeutics. 23rd Edn. Popular Prakashan, Mumbai; 2013. p. 818.
5. Rang HB, Dale MM, Rither JM. Pharmacology. 4th Edition: Churchill Livingstone; 1999. p. 725-31.
6. SK Berar. Essentials of pharmaceutics. 6th edn. Chand and Company Ltd, New Delhi; 2000. p. 458-9.
7. Nachname, Vorname. Derivative-differential UV spectrophotometry and compensation technique for the simultaneous determination of zidovudine and lamivudine in human serum. Die Pharmazie Int J Pharm Sci 2004;59:106-11.
8. SavaÅŸer A. Determination of abacavir, lamivudine and zidovudine in pharmaceutical tablets, human serum and in drug dissolution studies by HPLC. Chromatographia 2007;65:259-65.
9. Jayaseelan S. A new analytical method development and validation for the simultaneous estimation of lamivudine and stavudine in tablet dosage form by RP-HPLC method. Int J Pharm Tech Res 2010;2:1539-42.
10. Manikanta Kumar A, B Naga, Abstract Sandhya, Mahesh Nasare, VVLN Prasad, Prakash V Diwan. Development and validation of UV spectrophotometric method for simultaneous estimation of lamivudine and efavirenz in the pharmaceutical dosage form. J Adv Pharm Education Res 2012;2:210-4.
11. Nevens, Frederik. Lamivudine therapy for chronic hepatitis B: a six-month randomized dose-ranging study. Gastro-enterology 1997;113:1258-63.
12. PV Rajesh, CP Karunasree, G Dharmamoorthy, K Padmini, CH Sudeer. Development and partial validation of the lamivudine drug in bulk and solid dosage form by uv spectroscopy. IJPDT 2012;2:15-9.
13. SteinmÃ¼ller, Thomas. Increasing applicability of liver transplantation for patients with hepatitis Bâ€“related liver disease. Hepatology 2002;35:1528-35.
14. ICH draft Guidelines on Validation of Analytical Procedures: Definitions and Terminology, Federal Register, 60, IFPMA, Switzerland; 1995. p. 1260.
15. Becket AH, Stenlak JB. Practical pharmaceutical chemistry. 4th Edn. CBS Publisher and Distribution, New Delhi; 2004. p. 275-337.
16. Mendham J, Denney RC. Vogelâ€™s Textbook of Quantative Chemical Analysis. 6th Edn. Dorling Kindersley Pvt. Ltd New Delhi; 2006. p. 704-15.
17. Willard H Hobart, Merritt L. Lynne; Instrumental method of analysis. 1st edn CBS Publishers and Distribution, New Delhi; 1986. p. 164-84.
18. Lahane SB, Deokate UA. Development and validated UV spectrophotometric method for estimation of Albendazole in tablet dosage form. WJPR 2014;3:1461-7.
19. British Pharmacopoeia. Vol. I. Published by the stationary office on behalf of the Medicine and Healthcare Products Regulatory Agencies, London; 2008. p. 76-7.
20. United States Pharmacopoeia. In Validation of Compendial Methods. 26th edn: Pharmacopoeial Convention Inc., Rockville; 2003. p. 2439â€“42.
21. Indian Pharmacopoeia. Vol. II. Ministry of Health and Family Welfare Government of India: Published by Indian Pharmacopoeia Commission, Ghaziabad; 2007. p. 692-3.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.