Volume : 11, Issue : 06, June – 2024
Title:
NEWER RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF FORMOTEROL FUMARATE AND BUDESONIDE IN DOSAGE FORM
Authors :
Srinivas Nandyala, P.S.S. Prasanna Kumar, K. Tejaswi, Ramya Sri. S
Abstract :
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Formoterol Fumarate and Budesonide, 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 Formoterol Fumarate and Budesonide was 2.121, 3.643 ±0.02min respectively. The method produce linear responses in the concentration range of 10-50mg/ml of Formoterol Fumarate and 20-100mg/ml of Budesonide. 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: Formoterol Fumarate, Budesonide, RP-HPLC, validation.
Cite This Article:
Please cite this article in press Srinivas Nandyala et al, Newer RP-HPLC Method Development And Validation For The Simultaneous Estimation Of Formoterol Fumarate And Budesonide In Dosage Form.,Indo Am. J. P. Sci, 2024; 11 (06).
Number of Downloads : 10
References:
1. Council, G.M., Commission, G.B.M. British pharmacopoeia. General Medical Council, (2014)
2. Tan, K.S., Grove, A., McLean, A., Gnosspelius, Y., Hall, I.P., Lipworth, B.J.; Systemic corticosteriod rapidly reverses bronchodilator subsensitivity induced by formoterol in asthmatic patients; American Journal of Respiratory and Critical Care Medicine, (1997); 156: 28–35.
3. Barnes, P.J.; Inhaled corticosteroids; Pharmaceuticals, (2010); 3: 514–540.
4. Berger, W.E., Leflein, J.G., Geller, D.E., et al. .; The safety and clinical benefit of budesonide/formoterol pressurized metered-dose inhaler versus budesonide alone in children; Allergy and Asthma Proceedings : The Official Journal of Regional and State Allergy Societies, (2010); 31: 26–39.
5. Ganderton D, Lewis D, Davies R, Meakin B, Brambilla G, Church T. Modulite: a means of designing the aerosols generated by pressurized metered dose inhalers. Respir Med. 2002;96(Suppl D):S3–8.
6. Hareesha, N. & Manjunatha, J. G. Surfactant and polymer layered carbon composite electrochemical sensor for the analysis of estriol with ciprofloxacin. Mater. Res. Innov. 24, 349–362.
7. CazzolaMMolimardMThe scientific rationale for combining long-acting beta2-agonists and muscarinic antagonists in COPDPulm Pharmacol Ther201023425726720381630
8. CalverleyPMBurgePSSpencerSAndersonJAJonesPWBronchodilator reversibility testing in chronic obstructive pulmonary diseaseThorax200358865966412885978
9. Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids. Eur Respir J. 2002;19:182–91.
10. John Adamovies, Chromatographic analysis of pharmaceutical, Marcel Dekker Inc. New York, 2nd ed, P.74, 5-15.
11. Gurdeep Chatwal, Sahm K. Anand. Instrumental methods of chemical analysis, 5th edition, Himalaya publishing house, New Delhi, 2002, P.1.1-1.8, 2.566-2.570
12. D. A. Skoog. J. Holler, T.A. Nieman. Principle of instrumental analysis, 5th edition, Saunders college publishing, 1998, P.778-787.
13. Skoog, Holler, Nieman. Principals of instrumental analysis 5th ed, Harcourt publishers international company, 2001, P.543-554.
14. William Kemp. Organic spectroscopy, Palgrave, New York, 2005, P.7-10, 328-330
15. P.D. Sethi. HPLC: Quantitative analysis pharmaceutical formulations, CBS publishers and distributors, New Delhi (India), 2001, P.3-137.
16. Michael E, Schartz IS, Krull. Analytical method development and validation. 2004, P. 25-46.
17. R. Snyder, J. Kirkland, L. Glajch. Practical HPLC method development, 2nd ed, A Wiley international publication, 1997, P.235,266-268,351-353.653-600.686-695.
18. Basic education in analytical chemistry. Analytical science, 2001:17(1).
19. Method validation guidelines international onference on harmonization; GENEVA; 1996
20. Berry RI, Nash AR. Pharmaceutical process validation, Analytical method validation, Marcel Dekker Inc. New work, 1993; 57:411-28
21. Anthony C Moffat, M David Osselton, Brian Widdop. Clarke’s analysis of drugs and poisons, Pharmaceutical press, London, 2004, P.1109-1110, 1601-1602.
22. Klaus Florey, Analysis profile of drugs substances, Academic press, New York, 2005, P.406-435.
23. P.N. Arora, P.K. Malhan. Biostatistics, Himalaya publishers house, India, P.113, 139-140,154.
24. Doserge, Wilson and Gisvold’s text book of organic medicinal and pharmaceutical chemistry, 8th ed, Lippincott company, 1982, P.183-197.