Volume : 11, Issue : 05, May – 2024

Title:

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DICLOFENAC Na AND PARACETAMOLIN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

Authors :

Katravath Sumithra *, Reshma P

Abstract :

A new simple, accurate, economic, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Paracetamol and Diclofenac Na, in its pure form as well as in pharmaceutical dosage form. Chromatography was carried out on X bridge C18 (4.6×150mm) 5 µ column using a mixture of Methanol: Phosphate Buffer pH-3.6 (30:70v/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 Paracetamol and Diclofenac Na was2.669, 3.855±0.02min respectively. The method produces linear responses in the concentration range of 10-50µg/ml of Paracetamol and 10-50µg/ml of Diclofenac Na. 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: Paracetamol and Diclofenac Na, RP-HPLC, Validation.

Cite This Article:

Please cite this article in press Katravath Sumithra et al, Analytical Method Development And Validation For The Simultaneous Estimation Of Diclofenac Na And Paracetamol in Bulk And Pharmaceutical Dosage Form By Using RP-HPLC .,Indo Am. J. P. Sci, 2024; 11 (5).

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,
4. Academic press, (1997), PP 24-37.
5. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.
6. Chromatography, (online). URL:http://en.wikipedia.org/wiki/Chromatography.
7. Meyer V.R. Practical High-Performance Liquid Chromatography, 4th Ed. England, John Wiley & Sons Ltd, (2004), PP 7-8.
8. Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.
9. Introduction to Column. (Online),URL:http://amitpatel745.topcities.com/index_files/study/column care.pdf
10. Detectors used in HPLC (online )URL:http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC
11. Detectors (online) ,URL:http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors/det_uvda.html
12. Draft ICH Guidelines on Validation of Analytical Procedures Definitions and terminology. Federal Register, vol 60. IFPMA, Switzerland, (1995), PP 1126.
13. Code Q2B, Validation of Analytical Procedures; Methodology. ICH Harmonized Tripartite Guidelines, Geneva, Switzerland, (1996), PP 1- 8.
14. Introduction to analytical method validation (online), available from: URL: http://www.standardbase.hu/tech/HPLC%20validation%20PE.pdf.
15. Data elements required for assay validation, (online) available from: URL: http://www.labcompliance.com/tutorial/methods/default.aspx.
16. Snyder LR practical HPLC method development, 2nd edition. John Wiley and sons, New York, (1997), PP 180-182.