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Abstract
A rapid and precise reverse phase High Performance Liquid Chromatographic method has been developed for the validation of Stavudine and Lamivudine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Phenomenex Gemini C18 (4.6×250mm) 5µ column using a mixture of Methanol: TEA Buffer (65:35 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 230nm. The retention time of the Stavudine and Lamivudine was 2.121, 3.643 ±0.02min respectively. The method produce linear responses in the concentration range of 5-25µg/ml of Stavudine and 18.75-93.75µg/ml of Lamivudine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
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References
- 1. Dr. Kealey, Haines PJ. Analytical chemistry. 1st ed. Bios Publisher; 2002. P. 1-7.
- 2. BraithWait A, Smith FJ. Chromatographic methods. 5th ed. Kluwer Academic Publishers; 1996. P. 1-2.
- 3. Weston A, Phyllisr. Brown, HPLC principle and practice. 1st ed. Academic press; 1997. P. 24-37.
- 4. Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. 1st ed. Wiley Interscience
- A JohnWiley & Sons, Inc Publishing House; 2007. P. 15-23.
- 5. Chromatography [online]. Wikipedia. Available from: http://en.wikipedia.org/wiki/Chromatography.
- 6. Meyer VR. Practical high-performance liquid chromatography. 4th ed. England: John Wiley & Sons Ltd; 2004. P. 7-8.
- 7. Sahajwalla CG a new drug development. Vol. 141. New York: Marcel Dekker, Inc; 2004. P. 421-6.
- 8. Introduction to column [online]. Available from: http://amitpatel745.topcities.com/index_files/study/columncare.pdf.
- 9. Detectors used in HPLC (online). Available from: http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC.
- 10. Detectors [online]. Available from: http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors/det_uvda.html.
- 11. Detectors [online]. Available from: http://www.dionex.com/enus/webdocs/64842-31644-02_PDA-100.pdf.
- 12. Detectors [online]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/8867705.
- 13. Detectors [online]. Available from: http://www.chem.agilent.com/Library/applications/59643559.pdf.
- 14. Detectors [online]. Available from: http://hplc.chem.shu.edu/new/hplcbook/detector.
- 15. Draft ICH. Guidelines on Validation of Analytical Procedures Definitions and terminology. Fed Regist. 1995;60:1126.
- 16. Code. Q2B, validation of analytical procedures; methodology. ICH harmonized tripartite guidelines. 1996:1-8.
References
1. Dr. Kealey, Haines PJ. Analytical chemistry. 1st ed. Bios Publisher; 2002. P. 1-7.
2. BraithWait A, Smith FJ. Chromatographic methods. 5th ed. Kluwer Academic Publishers; 1996. P. 1-2.
3. Weston A, Phyllisr. Brown, HPLC principle and practice. 1st ed. Academic press; 1997. P. 24-37.
4. Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. 1st ed. Wiley Interscience
A JohnWiley & Sons, Inc Publishing House; 2007. P. 15-23.
5. Chromatography [online]. Wikipedia. Available from: http://en.wikipedia.org/wiki/Chromatography.
6. Meyer VR. Practical high-performance liquid chromatography. 4th ed. England: John Wiley & Sons Ltd; 2004. P. 7-8.
7. Sahajwalla CG a new drug development. Vol. 141. New York: Marcel Dekker, Inc; 2004. P. 421-6.
8. Introduction to column [online]. Available from: http://amitpatel745.topcities.com/index_files/study/columncare.pdf.
9. Detectors used in HPLC (online). Available from: http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC.
10. Detectors [online]. Available from: http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors/det_uvda.html.
11. Detectors [online]. Available from: http://www.dionex.com/enus/webdocs/64842-31644-02_PDA-100.pdf.
12. Detectors [online]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/8867705.
13. Detectors [online]. Available from: http://www.chem.agilent.com/Library/applications/59643559.pdf.
14. Detectors [online]. Available from: http://hplc.chem.shu.edu/new/hplcbook/detector.
15. Draft ICH. Guidelines on Validation of Analytical Procedures Definitions and terminology. Fed Regist. 1995;60:1126.
16. Code. Q2B, validation of analytical procedures; methodology. ICH harmonized tripartite guidelines. 1996:1-8.