Volume : 10, Issue : 12, December – 2023

Title:

SIMULTANEOUS ESTIMATION OF MONTELUKAST AND DOXOFYLLINE BY USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY IN API AND MARKETED FORMULATION

Authors :

N. Prathyusha*, P. Sowjanya, Dr.G.Vijaya Kumar,B.Sravanthi

Abstract :

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Montelukast and Doxofylline, in its pure form as well as in tablet dosage form. Chromatography was carried out on X bridge C18 (4.6×150mm) 5µcolumn using a mixture of Methanol: Phosphate Buffer pH3 (60:40v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260nm. The retention time of the Montelukast and Doxofylline was 2.6, 3.8±0.02min respectively. The method produce linear responses in the concentration range of 5-25µg/ml of Montelukast and 20-100µg/ml of Doxofylline 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: Montelukast and Doxofylline, RP-HPLC, Validation, Precision.

Cite This Article:

Please cite this article in press N. Prathyusha et al Simultaneous Estimation Of Montelukast And Doxofylline By Using Reverse Phase High Performance Liquid Chromatography In Api And Marketed Formulation, Indo Am. J. P. Sci, 2023; 10 (12).

Number of Downloads : 10

References:

1. https://en.wikipedia.org/wiki/High-performance_liquid_chromatography
2. https://www.pharmaguideline.com/2021/10/pharmaceutical-analysis-definition-and-scope.html
3. https://microbenotes.com/high-performance-liquid-chromatography-hplc/
4. Meyer V.R. Practical High-Performance Liquid Chromatography, 4thEd. England, John Wiley & Sons Ltd, (2004), PP 7-8.
5. Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.
6. Introduction to Column. (Online),URL:http://amitpatel745.topcities.com/index_files/study/column care.pdf
7. Detectors used in HPLC (online )URL:http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC
8. Detectors (online) ,URL:http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors/det_uvda.html
9. Dr.Kealey and P.J.Haines, Analytical Chemistry, 1stedition, Bios Publisher,(2002),PP:1-7.
10. A.BraithWait and F.J.Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
11. Andrea Weston and Phyllisr. Brown, HPLC Principle and Practice, 1st edition,Academic press, (1997), PP 24-37.
12. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.
13. Chromatography, (online). URL:http://en.wikipedia.org/wiki/Chromatography.
14. Draft ICH Guidelines on Validation of Analytical Procedures Definitions and terminology. Federal Register, vol 60. IFPMA, Switzerland, (1995), PP 1126.
15. Code Q2B, Validation of Analytical Procedures; Methodology. ICH Harmonized Tripartite Guidelines, Geneva, Switzerland, (1996), PP 1- 8.
16. Introduction to analytical method validation (online), available from: URL: http://www.standardbase.hu/tech/HPLC%20validation%20PE.pdf.