Abstract

COLLADO COELLO, Anna Karelia et al. Validation of a analytical method for quality control and stability study of 100 mg.mL injectable Ribavirin. Rev Cubana Farm [online]. 2010, vol.44, n.4, pp.485-493. ISSN 0034-7515.

The 100 mg/mL Ribavirin injectable is used in medical practice as a broad spectrum antiviral combined in an effective way with 2 â-á-Interferon against a great variety of ADN and ARN viruses. En present paper an analytical method by a high ressolution liquid chromatography to quality control and stability studies of 100l mg/ml Ribavirin injectable. Method was based on separation of active principle through a Lichrospher RP-18 (5 µm) (250 x 4 mm) chromatography column with UV detection at 207 nm using a mobile phase composed by a dihydrogen phosphate of 0.01 Ma pH 4.5 with a flow speed of 1.0 mL/min. Calibration curve was carried out in the 60-140 % interval where it was linear with a correlation coefficient similar to 0.9996, statistical test for the interceptive and slope weren't significant. A recovery of 99.87 % was achieved in the interval of study concentrations and the Cochran's and Students's tests (G). Variation coeficient in repetition study was similar to 0.79 % for the six assayed replicas whereas in intermdiate accuracy analysis the Fischer's and Student's tests weren't sinificant. Nalytical method was linear, accuracy, specific and exact in the interval of study concentrations.

Keywords : HPLC/methods; Ribavirin; validation.

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