%0 Journal Article
%T A Stability-Indicating High Performance Liquid Chromatographic Assay for the Simultaneous Determination of Pyridoxine, Ethionamide, and Moxifloxacin in Fixed Dose Combination Tablets
%A Munib-ur-Rehman
%A Rabia Ismail Yousuf
%A Muhammad Harris Shoaib
%J Chromatography Research International
%D 2014
%I Hindawi Publishing Corporation
%R 10.1155/2014/258125
%X Stability indicating reversed phase HPLC method was developed and validated for the simultaneous quantitation of antitubercular drugs, ethionamide (ETH), and moxifloxacin (MOX) with commonly coprescribed vitamin, pyridoxine (PYR) in tablet dosage form. The method was found rapid, precise and accurate. The separation was performed in Hibar 150-4.6, Purospher STAR, RP-18e (5ˋ米m) column, using mobile phase A (0.03ˋM sodium citrate adjusted to pH 5 with glacial acetic acid) and mobile phase B (100% methanol), ran at variable proportions at flow rate of 1.0ˋmL/min. The detection was carried out at 320ˋnm. The method was observed linearly in the range of 2.5每17.5ˋ米g/mL for PYR, 25每175ˋ米g/mL for ETH, and 40每280ˋ米g/mL for MOX with respective limits of detection/quantitation of 0.125ˋ米g/mL/1.28ˋ米g/mL, 0.25ˋ米g/mL/2.56ˋ米g/mL, and 0.35ˋ米g/mL/3.65ˋ米g/mL. The drugs were also subjected to oxidative, hydrolytic, photolytic, and thermal degradation; the degradation products showed interference with the detection of PYR, ETH, and MOX. The proposed method was observed to be effective to quantitate MOX (400ˋmg), ETH (250ˋmg), and PYR (25ˋmg) in fixed dose combination tablet formulation. 1. Introduction Moxifloxacin is a fluoroquinolones antibacterial agent having potent activity against M. tuberculosis, including MDR strains in 400ˋmg daily dose. Ethionamide is a traditional second line therapy drug for the treatment of tuberculosis in 250每1000ˋmg daily dose to avoid rapid development of resistance [1每6]. In order to reduce the problems associated with peripheral neuropathy caused by daily high dose of ethionamide therapy, pyridoxine dose ranging from 2.5 to 25ˋmg is usually added typically along with the above mentioned therapies [7]. In present work, a fixed dose combination of moxifloxacin 400ˋmg, ethionamide 250ˋmg, and pyridoxine 25ˋmg was designed to reduce the duration and neurologic side effects associated with antitubercular therapy (Figure 1) [8, 9]. Figure 1: Chemical structures of (1) pyridoxine, (2) ethionamide, (3) moxifloxacin, and (4) ciprofloxacin. The literature [8每21] and official monographs of BP [16] and USP [17] present spectrophotometric and HPLC methods for the individual quantitative determination of PYR, ETH, and MOX from the bulk and dosage forms. Therefore, in this study, a rapid, precise, and accurate reversed phase HPLC method was developed and validated for the simultaneous estimation of these drugs. But there is no stability indicating HPLC method available for the determination of these drugs. A drug and drug product is regarded as stable
%U http://www.hindawi.com/journals/cri/2014/258125/