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Memorias del Instituto de Investigaciones en Ciencias de la Salud

versão On-line ISSN 1812-9528

Resumo

ROIG, C et al. Validation of a high resolution liquid chromatography method (HPLC) for the determination of ivabradine tablets. Mem. Inst. Investig. Cienc. Salud [online]. 2012, vol.10, n.2, pp.63-70. ISSN 1812-9528.

We present the results obtained in the validation of an analytical method, performed by high resolution liquid chromatography for the determination of ivabradine in tablets, which was designed to identify and quantify this analyte using an RP18 (150 x 4.6 mm) 5 mm column and a UV-Vis detector at λ: 285 nm. This method will be used to control the quality and stability of ivabradine tablets. The method was validated using a work methodology that followed the guidelines of The International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures (ICH Q2). The following results were obtained: linearity (r2 = 0.999), precision Relative Standard Deviation (RSD) = 0.67 for pilot lot tablets and RSD = 0.31% for commercial lot tablets and accuracy, mean recovery = 100.2% thus demonstrating that the proposed method is applicable to the dosage of ivabradine in tablet form, both in the finished product analysis as in the stability studies.

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