Volume : 10, Issue : 09, September – 2023

Title:

18.A VALIDATED REVERSE PHASE-HPLC-PDA METHOD AND OPTIMIZATION OF METHOD AND ITS VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SULFADOXINE AND PYRIMETHAMINE IN PURE AND PHARMACEUTICAL DOSAGE FORM

Authors :

BOTTA SUPRIYA*, K.CHAITANYA PRASAD, B.SUDHAKAR, R.MOUNIKA

Abstract :

A new, simple and accurate, precise RP-HPLC method was developed for simultaneous determination of Sulfadoxine and Pyrimethamine in bulk and in combined pharmaceutical dosage form. The separation of Sulfadoxine and Pyrimethamine was achieved within 8 minutes on an Agilent Zorbax (C18) (150mm x 4.6mm, 5µm) column using Methanol: Acetate Buffer pH-3.8 (24:76v/v) as the mobile phase. Detection was carried out using wavelength at 262nm. The method showed adequate sensitivity concerning linearity, accuracy and precision over the range 100-500μg/ml and 30-70μg/ml for Sulfadoxine and Pyrimethamine, respectively. Careful validation proved advantages of high sensitivity, accuracy, precision, selectivity, robust and suitability for quality control laboratories. The developed method was robust as the %RSD was within the range and without effecting system suitability parameters. The proposed method is suitable for simultaneous determination of Sulfadoxine and Pyrimethamine in bulk and pharmaceutical dosage form.
Keywords: Sulfadoxine and Pyrimethamine, RP-HPLC, Validation, Precision, Robustness.

Cite This Article:

Please cite this article in press Botta Supriya et al, A Validated Reverse Phase-HPLC-PDA Method And Optimization Of Method And Its Validation For The Simultaneous Estimation Of Sulfadoxine And Pyrimethamine In Pure And Pharmaceutical Dosage Form, Indo Am. J. P. Sci, 2023; 10 (09).

Number of Downloads : 10

References:

1. Berry RI, Nash AR. Pharmaceutical process validation, Analytical method validation, Marcel Dekker Inc. New work, 1993; 57:411-28
2. Anthony C Moffat, M David Osselton, Brian Widdop. Clarke’s analysis of drugs and poisons, Pharmaceutical press, London, 2004, P.1109-1110, 1601-1602.
3. Klaus Florey, Analysis profile of drugs substances, Academic press, New York, 2005, P.406-435.
4. P.D. Sethi. HPLC: Quantitative analysis pharmaceutical formulations, CBS publishers and distributors, New Delhi (India), 2001, P.3-137.
5. Michael E, Schartz IS, Krull. Analytical method development and validation. 2004, P. 25-46.
6. 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.
7. Basic education in analytical chemistry. Analytical science, 2001:17(1).
8. Method validation guidelines international Conference on harmonization; GENEVA; 1996.
9. Sharma BK. Instrumental methods of chemical analysis, Introduction to analytical chemistry, 23th ed. Goel publishing house Meerut, 2004, P12-23.
10. 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.
11. John Adamovies, Chromatographic analysis of pharmaceutical, Marcel Dekker Inc. New York, 2nd ed, P.74, 5-15.
12. 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
13. D. A. Skoog. J. Holler, T.A. Nieman. Principle of instrumental analysis, 5th edition, Saunders college publishing, 1998, P.778-787.
14. Skoog, Holler, Nieman. Principals of instrumental analysis 5th ed, Harcourt Publishers international company, 2001, P.543-554.
15. William Kemp. Organic spectroscopy, Palgrave, New York, 2005, P.7-10, 328-330.
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.
18. https://www.drugbank.ca/drugs/DB01299
19. https://pubchem.ncbi.nlm.nih.gov/compound/Sulfadoxine
20. https://en.wikipedia.org/wiki/Sulfadoxine