Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Reverse Phase High Pressure Liquid Chromatogra-phic Determination of Rifampin Quinone and Hydra-zone in Anti-tuberculosis Fixed-Dose Formulations Containing Sodium Ascorbate as Anti-oxidant

P Umapathi , J Ayyappan, Darlin Quine

Department of Analytical Research and Development, Micro Labs Ltd, 67/68-A, Third Phase, Peenya Industrial Area, Bangalore 560 058, India;

For correspondence:- P Umapathi Email: umpy04@yahoo.com Tel:+918028379197

Received: 11 June 2010 Accepted: 17 October 2010 Published: 23 December 2010

Citation: Umapathi P, Ayyappan J, Quine D. Reverse Phase High Pressure Liquid Chromatogra-phic Determination of Rifampin Quinone and Hydra-zone in Anti-tuberculosis Fixed-Dose Formulations Containing Sodium Ascorbate as Anti-oxidant. Trop J Pharm Res 2010; 9(6):587-593 doi: 10.4314/tjpr.v9i6.10

© 2010 The authors.
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Abstract

Purpose: To establish the method for the analysis of rifampin quinone and hydrazone in fixed-dose combination tablets (FDC) containing rifampicin with or without sodium ascorbate as an additive.

Methods: The International Pharmacopoeial (IP) method for the estimation of rifampin quinone in FDC was modified. The extraction solvent (methanol/buffer mixture) of the IP method was replaced with ethyl acetate, in order to stabilize rifampin quinone in sample solutions of FDC containing sodium ascorbate as an ingredient.

Results: Rifampin quinone in FDC samples containing sodium ascorbate, which is not detectable in the IP method, was found to be 1.15 % (4-FDC), 1.52 % (3-FDC) and 1.60 % (2-FDC) using the modified method. Recovery of rifampin quinone in spiked samples of FDCs was practically nil in IP method whereas the recovery was 99.95%, 99.39 and 99.02 % for 4–FDC, 3-FDC and 2-FDC, respectively.

Conclusion: This modified method was suitable for the determination of rifampin quinone in fixed-dose formulations of rifampin both in the presence and absence of sodium ascorbate. The method is specific, precise, accurate, robust, rugged and gives a linear response for the quantitative estimation of rifampin quinone and hydrazone in fixed-dose combination tablets containing rifampin.

Keywords: Fixed dose combination; Rifampin quinone; Tuberculosis; Sodium ascorbate; Quantitative determination; HPLC