Development and validation of UV Spectrophotometric method for simultaneous estimation of Lamivudine and Tenofovir Disproxil Fumarate in the combined dosage form
A Simple, precise, accurate and economical spectrophotometric method was developed and validated for simultaneous estimation of Lamivudine (LAM) and Tenofovir disoproxil fumarate (TDF) in combined dosage form. In simultaneous equation method, LAM and TDF were quantified using their absorptivity values at selected wavelengths, viz., 276nm and 260nm respectively in water solvent system. LAM and TDF obeyed Beer’s law in the concentration range of 5-25μg/ml. Different analytical parameters such as linearity, precision, accuracy, limit of detection (LOD) and limit of quantification (LOQ) were determined as per ICH guidelines (Q2A & Q2B). % Recovery for both the drugs were in the range of 98.31-98.94% indicating excellent accuracy. The methods were precise, with a relative standard deviation of less than 2% for both drugs. The simultaneous equation method permits simple, rapid and direct determination of LAM and TDF in commercially available combined dosage form without previous separations and can therefore be used for routine analysis.
Keywords: Lamivudine, Tenofovir disoproxil fumarate, Spectrophotometric analysis, Simultaneous equation method.
3. Shirkhedkar A A, Bhirud C H, Surana S J (2009) Application of UVSpectrophotometric Methods for Estimation of Tenofovir Disoproxil Fumarate in Tablets. Pak J Pharm Sci 22(1): 27-29.
4. Sparidans R W, Crommentuyn K M, Schellens J H, Beijnen J H (2003) Liquid- Chromatography assay for the antiviral nucleotide analogue tenofovir in plasma using derivitization with chloroacetaldehyde. J Chromatogr B 791: 227-33.
5. Sentenac S, Fernandez C, Thuillier A, Lechat P and Aymard G (2003) Sensitive determination of tenofovir in human plasma samples using reversed-phase liquidchromatography. J Chromatogr B 793(2): 317-24.
6. Kandagal P B, Manjunatha D H, Seetharamappa J and Kalanur S S (2008) RP-HPLC method for the determination of tenofovir in pharmaceutical formulations and spiked human plasma. Anal Lett 41(4): 561-70.
7. Delahunty T, Bushman L, Fletcher C V (2006) Sensitive assay for determining plasma tenofovir concentrations by LC/MS/MS. J Chromatogr B 830: 6-12.
8. Massaki T, Yuichi K, Naoya O, Atsushi H, Kazuhide B, Tsuguhiro K (2007) Determination of plasma tenofovir concentration using a conventional LC-MS method. Biol Pharm Bull 30: 1784-86.
9. King T, Bushman L, Kiser J, Anderson P L, Michelle R, Delahunty T and Fletcher C V (2006) Liquid chromatography-tandem mass spectrometric determination of tenofovir-diphosphate in human peripheral blood mononuclear cells. J Chromato B 843(2,7): 147-56.
10. Marc Schuman, Serge Schneider,Christine Omes, Robert Wennig, Leon Fundira, Jean- Claude Tayari and Vic Arendt (2005) HPLC analysis of generic antiretroviral drugs purchased in Rwanda. Bull Soc Sci Med 3: 317 – 325.
11. Basavaiah K and Somashekar B C (2006) Titrimetric and Spectrophotometric methods for the assay of Lamivudine in Pharmaceuticals. J Sci Ind Res 65: 349 – 354.
12. Basavaiah K, Somashekar B C and Ramakrishna V (2007) Rapid titrimetric and spectrophotometric assay methods for the determination of lamivudine in Pharmaceuticals using iodate and two dyes. J Anal Chem 62 (6): 542 – 548.
13. Gholamreza Bahrami, Shahla Mirzaeei, Amir Kiani and Bahareh Mohammadi (2005) High-performance liquid chromatographic determination of lamivudine in human serum using liquid–liquid extraction; application to pharmacokinetic studies. J Chromatogr B 823 (2): 213 – 217.
14. Sibel A, OzkanBengi and Uslu (2002) Rapid HPLC Assay for Lamivudine in Pharmaceuticals and Human Serum. J Liq Chromatogr and Rel Tech 25 (9): 1447 – 1456.
15. Eunice Kazue Kano, Cristina Helena dos Reis Serra, Eunice Emiko Mori Koono and Simone Schramm (2006) Determination of lamivudine in human plasma by HPLC and its use in bioequivalence studies. J Pharm Biomed Anal 4 (3): 761 – 765.
16. Beckett AH, Stanlake JB. Practical Pharmaceutical Chemistry, fourth ed., part 2. CBS Publishers and Distributors, New Delhi 1997.
17. ICH Guidelines: Validation of Analytical Procedures: Text and Methodology Q2 (B), 2005.
18. Laxman R, Acharya A, Jain V, Bhardwaj S, Jain D. Development and validation of RP-HPLC and ultraviolet spectrophotometric methods simultaneous determination of spironolactone and torsemide in pharmaceutical dosage form. Int J Res Ayurveda Pharm 2010; 1(2):459-467
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).