Validation of a liquid chromatographic method for determination of tacrolimus in pharmaceutical dosage forms.
An accurate, simple, and reproducible liquid chromatographic method was developed and validated for the determination of tacrolimus in capsules. The analysis is performed at room temperature on a reversed-phase C18 column with UV detection at 210 nm. The mobile phase is methanol-water (90 + 10) at a constant flow rate of 0.8 mL/min. The method was validated in terms of linearity, precision, accuracy, and specificity by forced decomposition of tacrolimus, using acid, base, water, hydrogen peroxide, heat, and light. The response was linear in the range of 0.09-0.24 mg/mL (r2 = 0.9997). The relative standard deviation values for intra- and interday precision studies were 1.28 and 2.91%, respectively. Recoveries ranged from 98.06 to 102.52%.
Moyano
María A
MA
Universidad de Buenos Aires, Facultad de Farmacia y Bioquimica, Cátedra de Control de Calidad de Medicamentos, Junin 956, 1113 Buenos Aires, Argentina.
Simionato
Laura D
LD
Pizzorno
María T
MT
Segall
Adriana I
AI
D002853:Chromatography, Liquid; D004304:Dosage Forms; D007166:Immunosuppressive Agents / Q000032:analysis*; D007202:Indicators and Reagents; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet; D016559:Tacrolimus / Q000032:analysis*
D004304:Dosage Forms; D007166:Immunosuppressive Agents; D007202:Indicators and Reagents; D012996:Solutions; D016559:Tacrolimus