Abstract

BENITEZ HECHAVARRIA, Ernesto; NUNEZ CUADRA, Maryori; COLINDRES GALINDO, German Eduardo  and  MONCADA MENDOZA, Keiryn Merary. Ranitidine hydrochloride assay by high resolution liquid chromatography in an injectable solution. Rev. colomb. cienc. quim. farm. [online]. 2014, vol.43, n.1, pp.86-103. ISSN 0034-7418.  https://doi.org/10.15446/rcciquifa.v43n1.45466.

The United States Pharmacopeia instructs for the determination of ranitidine hydrochloride in an injectable solution but when we tried to reproduce this monograph, the ranitidine was not adsorbed in a similar column as the recommended. The aim of the present work was to validate an alternate method for the determination of ranitidine hydrochloride in an injectable solution. The alternate method was the one described in the United States Pharmacopeia for the determination of ranitidine hydrochloride (active pharmaceutical ingredient), with modifications. The method was validated as per Q2(R1) Guideline, of the International Conference on Harmonization. Method´s uncertainty was also determined. The coefficient of variation obtained for intermediate precision was less than 1.0 %; in the accuracy, the recovery was 100.30 % and the linearity showed absence of curvature in the range of 80 to 120 %. The expanded uncertainty calculated was less than 2 % of the amounts in the samples. All validation parameters evaluated were within acceptation limits established, therefore it is concluded that the method is suitable for the intended purposes.

Keywords : Ranitidine hydrochloride; High Performance Liquid Chromatography; HPLC; validation; uncertainty.

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