Development and Validation of an HPLC Method for Simultaneous Determination of Rifampicin, Isoniazid, Pyrazinamide, and Ethambutol Hydrochloride in Pharmaceutical Formulations

被引：33

作者：

Chellini, Paula R. ^{[1
]}

Lages, Eduardo B. ^{[1
]}

Franco, Pedro H. C. ^{[1
]}

Nogueira, Fernando H. A. ^{[1
]}

Cesar, Isabela C. ^{[1
]}

Pianetti, Gerson A. ^{[1
]}

机构：

[1] Univ Fed Minas Gerais, Fac Farm, Dept Prod Farmaceut, BR-31270901 Belo Horizonte, MG, Brazil

来源：

JOURNAL OF AOAC INTERNATIONAL | 2015年 / 98卷 / 05期

关键词：

ANTITUBERCULOSIS DRUGS; BIOAVAILABILITY; PRODUCTS;

D O I：

10.5740/jaoacint.14-237

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

Tuberculosis treatment consists of a fixed dose combination of rifampicin (RIF), isoniazid (INH), pyrazinamide (PYZ), and ethambutol hydrochloride (EMB). The combined treatment using various drugs is necessary for patient curing, without recrudescence, and for prevention of drug-resistant mutants, which may occur during treatment. An HPLC-diode array detector (DAD) method for the simultaneous determination of RIF, INH, PYZ, and EMB in fixed dose combination tablets was developed and validated. Chromatographic experiments were performed on an Agilent 1200 HPLC system, and the separation was carried out on a Purospher STAR RP18e (250 x 4.6 mm id, 5 pm, Merck) analytical column. Gradient elution was carried out with a mobile phase of 20 mM monobasic sodium phosphate buffer with 0.2% triethylamine (pH 7.0) and acetonitrile at a flow rate of 1.5 mL/min. The total run time was 12 min, and the re-equilibration time was 5 min. EMB detection was performed at 210 nm, and RIF, INH, and PYZ were detected at 238 nm, using a DAD. The method proved to be specific, linear (r(2) > 0.99), precise (RSD <2%), accurate, and robust and may be applied to the QC analysis of pharmaceutical formulations.

引用

页码：1234 / 1239

页数：6

共 15 条

[1]

[Anonymous], 2003, GUIDE VALIDATION ANA

[2]

[Anonymous], 2012, OFF WEB SIT NOB PRIZ

[3]

[Anonymous], 2013, US PHARM, P5047

[4]

[Anonymous], 2005, VAL AN PROC TEXT MET

[5] Guidelines for calibration in analytical chemistry - Part 1. Fundamentals and single component calibration (IUPAC recommendations 1998) [J].

Danzer, K ;

Currie, LA .

PURE AND APPLIED CHEMISTRY, 1998, 70 (04) :993-1014

[6] Simultaneous determination of first-line anti-tuberculosis drugs by capillary zone electrophoresis using direct UV detection [J].

Faria, Adriana F. ;

de Souza, Marcus V. N. ;

Bruns, Roy E. ;

de Oliveira, Marcone A. L. .

TALANTA, 2010, 82 (01) :333-339

[7]

Kibbe A.H., 2000, HDB PHARM EXCIPIENTS

[8] Evaluation of the recently reported USP gradient HPLC method for analysis of anti-tuberculosis drugs for its ability to resolve degradation products of rifampicin [J].

Mohan, B ;

Sharda, N ;

Singh, S .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2003, 31 (03) :607-612

[9] Biopharmaceutic and pharmacokinetic aspects of variable bioavailability of rifampicin [J].

Panchagnula, R ;

Agrawal, S .

INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2004, 271 (1-2) :1-4

[10] Optimization of a reversed-phase-high-performance thin-layer chromatography method for the separation of isoniazid, ethambutol, rifampicin and pyrazinamide in fixed-dose combination antituberculosis tablets [J].

Shewiyo, D. H. ;

Kaale, E. ;

Risha, P. G. ;

Dejaegher, B. ;

Smeyers-Verbeke, J. ;

Vander Heyden, Y. .

JOURNAL OF CHROMATOGRAPHY A, 2012, 1260 :232-238

← 1 2 →