Determination of Main Component and the Related Substances in Pirenoxinum Natricum Eye Drops by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a HPLC method for the determination of main component and the related substances in pirenoxinum natricum eye drops. METHODS: A Inertsil C8-3 column was used with pH2.2 perchloric acid-methanol (35∶65) as mobile phase at a flow of 1.0 mL?min-1. The detection wavelength was 230 nm and the sample size was 10 ?L. RESULTS: Pirenoxinum natricum and the related substances could be baseline separated. The calibration curve was linear in the range of 49.5～990 ng(r=0.999 9). The detection limits was 89.3 pg, and average recovery was 99.1%, RSD was 0.42%. CONCLUSIONS: This method is rapid, accurate sensitive and can be used for the quality control of pirenoxinum natricum eye drops.