Method validation of hydroxysafflor yellow A in “Carthamus tinctorius” injection by High-performance liquid chromatography / Монголын Анагаах Ухаан

ABSTRACT

Introduction@#Carthamus tinctorius L. widely accepted as Safflower or false saffron, belongs to the Compositae or Asteraceae family. Hydroxysafflor yellow A is the main active chemical compound present in florets of Carthamus tinctorius L. A joint research team of the “Tsombo Pharm” Co., LTD and the Drug research Institute is conducting an experiment to produce a solution of “Carthamus tinctorius” injection prepared by Carthamus tinctorius L. @*Goal @#The aim of this study was to develop the validation method of hydroxysafflor yellow A in “Carthamus tinctorius” injection.@*Material and Methods @#As a test sample “Carthamus tinctorius” injection was produced by “Tsombo pharma” Co., LTD. The standard Hydroxysafflor yellow A was supplied from Sigma-Aldrich Co., Ltd. The reagent were high-performance liquid chromatography grade acetonitrile, phosphoric acid, methanol and purified water. </br> Shimadzu HPLC (CMB-20 A, UV detector Shimadzu SPD-20A was used as the analytical instrument and the analysis conditions were as follows Table 1. @*Results@#A Shimpack С18 column was used with methanolacetonitrile0.7% phosphoric acid as the mobile phase under the condition of gradient elution. The hydroxysafflor yellow A were analyzed by using a timed wavelength measure according to their maximum absorption wavelength. Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low (50%) middle (100%) and high (150%) concentrations. The intraday and interday precisions of the investigated compound were less than 1.59 % and the average recoveries ranged from 81.9% to 101.5%. </br> There were good linear correlations between the concentrations of the hydroxysafflor yellow A and its chromatographic peak areas (R2 = 0.998), the proposed method was successfully applied to determine the hydroxysafflor yellow A in “Carthamus tinctorius” injection. @*Conclusions@#The results indicated that the proposed method is simple, stable, and accurate and could be readily utilized as a quality control method for manufacturing process of “Carthamus tinctorius” injection.