Volume : 12, Issue : 01, January – 2025
Title:
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DEFLAZACORT BY USING RP-HPLC
Authors :
Jaishree.M, Nandhini.P, Priyanka. M, Deepa.G, Gokulan.P.D, SenthilKumar.K.L
Abstract :
A simple, rapid and selective RP-HPLC method was developed for the estimation of Deflazacort. Deflazacort is a corticosteroid which is an oxazoline derivative of prednisolone, characterized by a high binding affinity to tissue glucocorticoid receptors and exert anti- inflammatory and immunosuppressive effects. Deflazacort significantly inhibits both the proliferation of mononuclear cells derived from human peripheral blood, and the release of inflammatory cytokines by these cells. The method was validated for accuracy, precision, specificity, linearity and sensitivity. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The developed and validated method was successfully applied for the quantitative analysis of Deflazacort in pharmaceutical formulation. This research contributes to ensuring the quality and reliability of Deflazacort analysis in pharmaceutical laboratories.
Key words: Deflazacort, Reverse Phase HPLC, Method validation
Cite This Article:
Please cite this article in press Jaishree.M et al Analytical Method Development And Validation Of Deflazacort By Using RP-HPLC., Indo Am. J. P. Sci, 2025; 12 (01).
Number of Downloads : 10
References:
1) Markham A., Bryson H. Deflazacort: A review of its pharmacological properties and therapeutic efficacy. Drugs. 1995; 50: 317-33. 2) Cardoso S.
2) Development and validation of a reversed-phase HPLC method for the determination of deflazacort in pharmaceutical dosage forms. Chromatographia. 2007; 65: 591-594.
3) Santos-Montes A., Gasco-Lopez A.I., Izquierdo Hornillos R. Optimization of the high- performance liquid chromatrographic separation of a mixture of natural and synthetic corticosteroids. J. Chromatography. 1993; 620: 15- 23
4) Ravisankar P, Navya CN, Pravallika D, Sri DN. Et al., A review on step- by-step analytical method validation, IOSR J Pharm 2015;5:7-19.
5) Patel A, Dwivedi N, Kaurav N, Bashani S, Patel S, Sharma HS, et al. Chemical analysis of pharmaceuticals: a review. J Med Pharm Innov 2016; 3; 4-7 Chromatographia. 2021 Mar;84(3):285-95.
6) G. M. Corrêa, L. P. Bellé, L. Bajerski, S. H. M. Borgmann, S. G. Cardoso ”Development and Validation of a Reversed-Phase HPLC Method for the Determination of Deflazacort in Pharmaceutical Dosage Forms” May 2007.
7) Ahuja, S., & Munk, M. (2001). “Chromatographic analysis of pharmaceuticals.” John Wiley & Sons.
8) Sharma, A., & Agarwal, V. (2007). “High-performance liquid chromatographic method for determination of deflazacort in pharmaceutical dosage forms.” Journal of Chromatography B, 850(1-2), 376-380.
9) Prakash, A. (2009). “Development and validation of a RP-HPLC method for the estimation of deflazacort in tablet formulations.” Asian Journal of Pharmaceutical and Clinical Research, 2(1), 32-35.
10) Rathore, A. S., & Winkle, D. H. (2003). “Development and Validation of Analytical Methods in Pharmaceutical Development.” Pharmaceutical Technology, 27(7), 82–90.
11) ICH Q2(R1), (2005). Validation of Analytical Procedures: Text and Methodology. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).