Volume : 11, Issue : 10, October – 2024
Title:
NEW ANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR THE DETERMINATION OF FOSTEMSAVIR & GANCICLOVIR IN BULK DRUG & FORMULATION BY RP-HPLC.
Authors :
T.Ravali*, Dr.B.Sudhakar,K.Chaitanyaprasad,Dr.K.Shravankumar
Abstract :
High performance liquid chromatography (HPLC) is an essential analytical tool in assessing drug product. HPLC methods should be able to separate, detect, and quantify the various drugs and drug related degradants that can form on storage or manufacturing, detect and quantify any drugs and drug-related impurities that may be introduced during synthesis. A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Fostemsavir and Ganciclovir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a X-Terra C18 (4.6×150mm) 5µ column using a mixture of Methanol: Water (65:35%v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 220nm. The retention time of the Fostemsavir and Ganciclovir was 2.9, 3.6 ±0.02min respectively. 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.
Keywords: Ganciclovir, Fostemsavir, RP-HPLC, validation.
Cite This Article:
Please cite this article in press T.Ravali et al., New Analytical Method Development & Validation For The Determination Of Fostemsavir & Ganciclovir In Bulk Drug & Formulation By RP-HPLC..,Indo Am. J. P. Sci, 2024; 11 (10).
Number of Downloads : 10
References:
1. Dr. Kealey and P.J Haines, Analytical Chemistry, 1stedition, Bios Publisher, (2002), PP 1-7.
2. A.BraithWait and F.J.Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
3. Andrea Weston and Phyllisr. Brown, HPLC Principle and Practice, 1st edition,
Academic press, (1997), PP 24-37.
4. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.
5. Chromatography, (online). URL:http://en.wikipedia.org/wiki/Chromatography.
6. Meyer V.R. Practical High-Performance Liquid Chromatography, 4th Ed. England, John Wiley & Sons Ltd, (2004), PP 7-8.
7. Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.
8. Introduction to Column. (Online),URL:http://amitpatel745.topcities.com/index_files/study/column care.pdf
9. Detectors used in HPLC (online )URL:http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC
10. Detectors (online) ,URL:http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors/det_uvda.html
11. Detectors (online) ,URL:http://www.dionex.com/enus/webdocs/64842-31644-02_PDA-100.pdf
12. Detectors (online),URL:http://www.ncbi.nlm.nih.gov/pubmed/8867705
13. Detectors (online),URL:http://www.chem.agilent.com/Library/applications/59643559.pdf
14. Detectors (online),URL:http://hplc.chem.shu.edu/new/hplcbook/detector
15. Draft ICH Guidelines on Validation of Analytical Procedures Definitions and terminology. Federal Register, vol 60. IFPMA, Switzerland, (1995), PP 1126.