Quality Control of Jinniu Ophthalmic Remedy / 中国药师

ABSTRACT

Objective:To develop the methods for the determination of calcined calamine and borneol in Jinniu ophthalmic remedy. Methods:The content of zinc oxide in calcined calamine was determined by an EDTA coordination titration method. A DB-WAX capillary column (30 m ×0.32 mm,0.5 μm) was used with an FID as the detector and ethylacetate as the solvent to determine the content of borneol. The column temperature was 150 ℃, the injection port temperature was 180 ℃, the detector temperature was 200 ℃, the split ratio was 51,and the flow rate was 1 ml·min-1. Results:The recovery of zinc oxide was 101.5% with the RSD was 1.2%(n = 9). The linear range of borneol was 0.1-5.0 μg(r = 0.999 9). The recovery of borneol was 98.18% with the RSD was 0.8%(n = 9). The content of zinc oxide and borneol in the samples was 0.38-0.59 g·g-1and 0.13-0.21 g·g-1,respectively. Conclusion:The method is simple and accurate with high reproducibility and promising stability, which can be used for the quality control of Jinniu ophthalmic remedy.