HPLC Analysis of a New Granulated Preparation Containing Isoniazid and Pyridoxine Hydrochloride

Abstract

A new ready-to-use medicinal form -granules containing isoniazid and pyridoxine hydrochloride (0.15 and 0.015 g per gram of granules, respectively) -has been recently developed. An HPLC technique for the qualitative and quantitative analysis of the new preparation is described. The analyses are carried out using a Millihrom-2 chromatograph equipped with a UV detector and a KAKh 4-64-3 column filled with Separon C 18 . The column is eluted with an acetonitrile -0.5% aqueous sodium dihydrophosphate solution (60:40, adjusted with orthophosphoric acid at pH 2.5 -3.0) at a flow rate of 50 ml/min. The detection is carried out at 280 nm. The relative error of determination does not exceed ± 1.1% for isoniazid and ± 4.1% for pyridoxine hydrochloride.

Validation of a rapid micellar electrokinetic capillary chromatographic method for the simultaneous determination of isoniazid and pyridoxine hydrochloride in pharmaceutical formulation

“…The calibration plots were constructed after analysis of eight different concentrations (3,5,10,20,25, 50, 75 and 100 g mL −1 for ISO and 1, 5, 7.5, 10, 25, 50, 75 and 100 g mL −1 for PYR) and each concentration was measured three times using the ratio of peak area method. This method was easy to use and the Relative standard deviation (R.S.D.)…”

“…There are various analytical procedures for the assay of either ISO or PYR in pharmaceutical preparations and biological fluids, only three methods have been reported to be able to analyze both drugs in combination [3][4][5]. These methods used high-pressure liquid chromatography (HPLC) [3], high performance thin layer chromatography [4] and spectrophotometry [5].…”

“…These methods used high-pressure liquid chromatography (HPLC) [3], high performance thin layer chromatography [4] and spectrophotometry [5]. Several capillary electrophoresis methods for quantitation of ISO [6][7][8][9][10] and PYR [11] have been reported.…”

A spectrophotometric micro determination of pyridoxine hydrochloride by coupling diazometry

“…Sevral analytical methods are available in the literature for the determination of pyridoxine in their pharmaceutical preparations including : HPLC (4)(5)(6)(7)(8) , reversed phase ion-pair HPLC (9) , capillary electrophoresis (10) , cyclic voltammetry (11,12) , flow injection analysis (13,14) and spectrophotometric methods (15) . Another spectrophotometric methods including derivative spectrophotometry with different order's (16,17) , spectrofluorometry (18) , oxidative coupling reaction (19) and coupling diazometry (20)(21)(22)(23) .…”

Development and validation of a stability indicating high-performance liquid chromatography (HPLC) method for the estimation of isoniazid and its related substances in fixed dose combination of isoniazid and ethambutol hydrochloride tablets

“…The WHO monograph for this fixed dose combination does not include the related substances test (International Pharmacopoeia, 2008). Although some methods have been reported for the estimation of isoniazid and its related compounds (Bhutani et al, 2007;Butterfield et al, 1980;Chen et al, 2005;Khuhawar et al, 2005Khuhawar et al, , 2006Kompantseva et al, 2005;Kulkarni et al, 2004;Musch et al, 1990;Wang et al, 2007) no method has been published thus far for the estimation of related compounds of isoniazid in the fixed dose combination of isoniazid and ethambutol HCl tablets. This work reports *Corresponding author.…”