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.
Department of Pharmaceutical Chemistry, University of Pavia, Via Taramelli 12, Pavia, Italy. enrica.calleri@unipv.it
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Calleri
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De Lorenzi
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Furlanetto
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Massolini
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Caccialanza
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