Volume : 11, Issue : 12, December – 2024

Title:

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF FLUCONAZOLE AND TINIDAZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Authors :

T.Venkatesh, M.Chaitanya, P.Aravindra Reddy

Abstract :

RP-HPLC method was developed and validated as per ICH guidelines for the estimation of Fluconazole and Tinidazole. Simultaneous Estimation of Fluconazole and Tinidazole were carried out by RP- HPLC using Ortho phosphoric acid buffer & methanol, and column Inertsil C18 (250*4.6 mm, 5um) as a stationary phase and peak was observed at 213 nm which was selected as a wavelength for quantitative estimation. After the development of the method, it was validated for various parameters. It was found that recovery value of pure drug was between 99 % to 101% which indicates that the method is accurate and also reveals that commonly used excipients and additives present in the pharmaceutical formulations were not interfering in the proposed methods. The ruggedness of the method was checked by different analysts and found that the results were nearly same which indicates that the method is rugged. Based on the results observed, it was concluded that proposed method can be used for routine analysis of fluconazole and tinidazole.
Key words: Fluconazole, Tinidazole anti-protozoal agent, linearity, accuracy, precision.

Cite This Article:

Please cite this article in press M.Chaitanya et al .,Method Development And Validation For Simultaneous Estimation Of Fluconazole And Tinidazole In Bulk And Pharmaceutical Dosage Forms By Rp-Hplc.,Indo Am. J. P. Sci, 2024; 11 (12).

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References:

1. Ganorkar SB, Shirkhedkar AA. Design of experiments in liquid chromatography (HPLC) analysis of pharmaceuticals: Analytics, applications, implications and future prospects. Reviews in Analytical Chemistry. 2017;36(3):1-43.
2. Awotwe-Otoo D, Agarabi C, Faustino PJ, Habib MJ, Lee S, Khan MA, Shah RB. Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate. Journal of pharmaceutical and biomedical analysis. 2012;62:61-7.
3. Siregar C, Prabaningdyah NK, Choiri S, Riyanto S, Rohman A. Optimization of HPLC using central composite design for determination of curcumin and demethoxycurcumin in tablet dosage form. Dhaka University Journal of Pharmaceutical Sciences. 2017;16(2):137-45.
4. Lestari AD, Rohman A, Martono S. Central Composite Design Applied in HPLC Optimization For Analysis of Tartrazine And Auramine O in Powder Drinks. International Journal of Applied Pharmaceutics. 2019;7:211-5.
5. International Union of Pure and Applied Chemistry. Plate number (in chromatography), IUPAC Compendium of Chemical Terminology, Research Triangle Park, NC. 1997.
6. McNair HM and Bonelli EJ (1969) Basic gas chromatography, Varian, Palo Alto, CA.1969.
7. Lindholm J. Development and validation of HPLC methods for analytical and preparative purposes (Doctoral dissertation, Acta Universitatis Upsaliensis).2004.
8. Guideline IH. Stability testing of new drug substances and products. Q1A (R2), current step. 2003;4:1-24.
9. Brummer H, “How to Approach a Forced Degradation Study”, Life sci. tech bul., 2011.
10. Urvi S, Nilesh P, Ashok P, Amit V, “Stability Indicating RP-HPL Method Developmen and Validation of remogliflozin etaboante and metformin hcl and its Degradant in its Capsule Dosage Form” J. Pharm. Sci. and Res., 2017; 9(9): 1549-155.
11. Harne UV, Birajdar L, Damle MC, “Development and validation of stability indicating HPLC method for determination ofremogliflozin etaboante” World J. Pharm. Res., 2017; 6(11): 430-441.
12. Harne UV, Birajdar L, Damle MC, “Development and validation of stability indicating HPLC method for determination of metformin hcl” World J. Pharm. Res., 2017; 6(11):430-432.
13. Saxena V, Zaheer Z, Farooqui M, “Stability Indicating RP-HPLC Method for the Determination of remogliflozin etaboante and metformin hcl in Pharmaceutical formulation” Ind. J. of Chem. Tech. Res., 2006; 13: 242-246.
14. Vasanthraju SG, Mishra A, Karthik A, Mausmade PP, Udupa N, “Stability Indicating RPHPLC Method For Determination of metformin hcl in Solid Dosage Form” J. Pharm. Res., 2009; 8(4): 184-186