Volume : 10, Issue : 09, September – 2023

Title:

44.RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF IFOSFAMIDE IN PURE FORM AND PHARMACEUTICAL DOSAGE FORM

Authors :

Dhobba. Prathima*, Mr. Kale parag

Abstract :

A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Ifosfamide in pure form and pharmaceutical dosage form. Separation of Ifosfamide was successfully achieved on a Symmetry ODS C18 (4.6 x 150mm, 5m) column in an isocratic mode utilizing ACN: Methanol in the ratio of 60:40% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 251nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 10-50mcg/mL for Ifosfamide. The correlation coefficient was found to be 0.999 for Ifosfamide. The LOD and LOQ for Ifosfamide were found to be 1.3µg/mL and 4.0µg/mL respectively. The proposed method was found to be good percentage recovery for Ifosfamide, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.
Keywords: Ifosfamide, RP-HPLC, Accuracy, ICH Guidelines.

Cite This Article:

Please cite this article in press Dhobba. Prathima et al, Rp-Hplc Method Development And Validation For The Estimation Of Ifosfamide In Pure Form And Pharmaceutical Dosage Form, Indo Am. J. P. Sci, 2023; 10 (09).

Number of Downloads : 10

References:

1. Sharma BK. Instrumental methods of chemical analysis, Introduction to analytical chemistry, 23th ed .Goel publishing house meerut, 2004,P12-23.
2. H.H. Willard, L.L. Merritt, J.A. Dean, F.A. Settle. Instrumental methods of analysis, 7th edition, CBS publishers and distributors, New Delhi. 1986, P.518-521, 580-610.
3. John Adamovies, Chromatographic analysis of pharmaceutical, Marcel Dekker Inc. New York, 2nd ed, P.74, 5-15.
4. 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
5. D. A. Skoog. J. Holler, T.A. Nieman. Principle of instrumental analysis, 5th edition, Saunders college publishing, 1998, P.778-787.
6. Skoog, Holler, Nieman. Principals of instrumental analysis 5th ed, Harcourt publishers international company, 2001, P.543-554.
7. William Kemp. Organic spectroscopy, Palgrave, New York, 2005, P.7-10, 328-330
8. P.D. Sethi. HPLC: Quantitative analysis pharmaceutical formulations, CBS publishers and distributors, New Delhi (India), 2001, P.3-137.
9. Michael E, Schartz IS, Krull. Analytical method development and validation. 2004, P. 25-46.
10. 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.
11. Basic education in analytical chemistry. Analytical science, 2001:17(1).
12. Method validation guidelines international onference on harmonization; GENEVA; 1996
13. Berry RI, Nash AR. Pharmaceutical process validation, Analytical method validation, Marcel Dekker Inc. New work, 1993; 57:411-28
14. Anthony C Moffat, M David Osselton, Brian Widdop. Clarke’s analysis of drugs and poisons, Pharmaceutical press, London, 2004, P.1109-1110, 1601-1602.
15. Klaus Florey, Analysis profile of drugs substances, Academic press, New York, 2005, P.406-435.
16. P.N. Arora, P.K. Malhan. Biostatistics, Himalaya publishers house, India, P.113,139-140,154.
17. Doserge, Wilson and Gisvold’s text book of organic medicinal and pharmaceutical chemistry, 8th ed, Lippincott Company, 1982, P.183-197.