Simple and Rapid Liquid Chromatographic Method for Determination of Histidine HCl in Pharmaceutical Preparations

Abstract

Histidine (HID) is frequently compounded in pharmaceutical preparations for the treatment of gastrointestinal diseases. A simple and rapid liquid chromatographic method was developed and validated for the routine determination of HID in pharmaceutical preparations. The high-performance liquid chromatographic (HPLC) system consisted of an Purospher STAR RP18 endcapped column (4.6×250 mmi. d.) using amobile phase of 50 mMphosphate buffer with 3 mM sodium octanesulfonate: acetonitrile (95:5, v/v) with an ultraviolet/visible (UV/VIS) detector at 210 nm. The developed method satisfies the system suitability criteria and peak integrity for HID. The square of the correlation coefficient of the linear regression analysis was 0.9995. The relative standard deviations (RSDs) for intra- and inter-day tests were less than 2%. The recovery for 5 concentrations expressed as the closeness of the observed mean to the spiked concentration was 98.20%~101.02%. The limits of detection (LOD) and quantitation (LOQ) for HID were 2.2 and 7.3 μg/mL, respectively. The method was applied to quantitatively determine HID in 8 brands of HID-containing tablets on the Taiwanese market, and these were found to contain 100.59%±1.01% of the percentage claimed on the label. The results indicate that the established assay method is suitable for measuring HID in pharmaceutical preparations.