Validation of a RP-LC method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin in a pharmaceutical formulation.
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.
Calleri
E
E
Department of Pharmaceutical Chemistry, University of Pavia, Via Taramelli 12, Pavia, Italy. enrica.calleri@unipv.it
De Lorenzi
E
E
Furlanetto
S
S
Massolini
G
G
Caccialanza
G
G
D000995:Antitubercular Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004338:Drug Combinations; D007538:Isoniazid / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000737:chemistry; D011718:Pyrazinamide / Q000032:analysis*; D015203:Reproducibility of Results; D012293:Rifampin / Q000032:analysis*; D012680:Sensitivity and Specificity
D000995:Antitubercular Agents; D004338:Drug Combinations; D004364:Pharmaceutical Preparations; D011718:Pyrazinamide; D007538:Isoniazid; D012293:Rifampin