Validation of a RP-LC method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin in a pharmaceutical formulation

J Pharm Biomed Anal. 2002 Aug 1;29(6):1089-96. doi: 10.1016/s0731-7085(02)00150-4.

Abstract

A simple and accurate liquid chromatographic method was developed and validated for estimation of isoniazid (ISN), pyrazinamide (PYR) and rifampicin (RIF) in combined dosage forms. Drugs were chromatographed on a reverse phase C18 column using a mobile phase gradient and monitored at the corresponding maximum of each compounds. Peaks were identified with retention time as compared with standards and confirmed with characteristic spectra using diode-array detector. Solution concentrations were measured on a weight basis to avoid the use of an internal standard. The method does not require any specific sample preparation except the use of a guard column. The method is linear (r(2)>0.999), precise (RSD%: 0.50% for ISN, 0.12% for PYR and 0.98% for RIF), accurate (overall average recovery yields: 98.55% for ISN, 98.51 for PYR and 98.56% for RIF) and selective. Due to its simplicity and accuracy the method is suitable for routine quality control analysis of antitubercolosis combination dosage form.

Publication types

  • Validation Study

MeSH terms

  • Antitubercular Agents / analysis*
  • Chromatography, High Pressure Liquid / methods*
  • Drug Combinations
  • Isoniazid / analysis*
  • Pharmaceutical Preparations / chemistry
  • Pyrazinamide / analysis*
  • Reproducibility of Results
  • Rifampin / analysis*
  • Sensitivity and Specificity

Substances

  • Antitubercular Agents
  • Drug Combinations
  • Pharmaceutical Preparations
  • Pyrazinamide
  • Isoniazid
  • Rifampin