Volume : 11, Issue : 06, June – 2024
Title:
SIMULTANEOUS ESTIMATION OF NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SULBACTAM, DURLOBACTAM BY HIGH
PERFORMANCE LIQUID CHROMATOGRAPHY
Authors :
Gadipally Saikiran*, Basa.Mounika, Dr.D.Venkata Ramana, Koppu Udaya Bhanu Sri
Abstract :
A simple, specific, precise, and efficient method for the Simultaneous estimation of Sulbactam and Durlobactam in pure and pharmaceutical dosage forms by a Reverse Phase-High Performance Liquid Chromatography method is developed and validated. Selected mobile phase were in a combination of Acetonitrile and Acetate buffer (pH-4.3) (35:65% v/v). Optimized column is a Develosil C18 (4.6mm×250mm) 5µm particle size and at a flow rate of 1.0mL/min with detection wavelength at 238nm for Sulbactam and Durlobactam. In our study, the validation of analytical method for determination of Sulbactam and Durlobactam in pure and pharmaceutical dosage forms was performed in accordance the parameters including-system suitability, specificity, linearity of response, accuracy, precision (reproducibility & repeatability), robustness (change of wave length±2 nm). The method is validated according to ICH guidelines. In RP-HPLC method, the calibration graphs were linear in the concentration range of 10-30μg/ml for Sulbactam and 30-90μg/ml for Durlobactam with percentage recoveries are within the limits. The results obtained by RP-HPLC methods are rapid, accurate and precise. Therefore, proposed method can be used for routine analysis of Sulbactam and Durlobactam in the pure form as well as in combined pharmaceutical dosage form.
Keywords: Sulbactam and Durlobactam, HPLC, Method Development, Validation.
Cite This Article:
Please cite this article in press Gadipally Saikiran et al, Simultaneous Estimation Of New Analytical Method Development And Validation Of Sulbactam, Durlobactam By High Performance Liquid Chromatography .,Indo Am. J. P. Sci, 2024; 11 (6).
Number of Downloads : 10
References:
1. Sharma BK. Instrumental methods of chemical analysis, Introduction to
analytical chemistry, 23 th 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, 7 th
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, 2 nd ed, P.74, 5-15.
4. Gurdeep Chatwal, Sahm K. Anand. Instrumental methods of chemical analysis, 5 th 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, 5 th edition, Saunders
college publishing, 1998, P.778-787.
6.Skoog, Holler, Nieman. Principals of instrumental analysis 5 th 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, 2 nd 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 Conference 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.