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vol.44 issue1Analytical methods validation of processes control in injectable antitumor agentsStudy of the 50 mg Propylthiouracil tablets stability author indexsubject indexarticles search
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Revista Cubana de Farmacia

Print version ISSN 0034-7515On-line version ISSN 1561-2988

Abstract

VALDES BENDOYRO, María Olga et al. Analytical method validation for quality control and the study of the 50 mg Propylthiouracil stability. Rev Cubana Farm [online]. 2010, vol.44, n.1, pp.21-29. ISSN 0034-7515.

A high-performance liquid chromatography analytical method was developed and validated for the quality control and stability studies of 50 mg Propylthiouracil tablets. Method is based in active principle separation through a 100 RP-18 RP-18 (5 µm) (250 x 4 mm) Lichrospher chromatography with UV detection to 272 nm, using a mobile phase composed by a ungaseous mixture of a 0.025 M buffer solution-monobasic potassium phosphate to pH= 4,6 ad acetonitrile in a 80:20 ratio with a flux speed of 0,5 mL/min. Analytical method was linear, precise, specific and exact in the study concentrations interval.

Keywords : High-performance liquid chromatography; methods; Propylthiouracil; validation.

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