Determination of atropine sulfate and related substances in Atropine Sulfate Eye Drops by HPLC.

Objective To establish a HPLC method for the determination of atropine sulfate and related substances in Atropine Sulfate Eye Drops. Methods A C18 column was used and the mobile phase was phosphate buffer-methanol (85:15). The detection wavelength was 206 nm. Results A linear plot of peak area versus concentration of atropine sulfate was obtained in the range of 25.98～519.5 μg·mL-1 (r=0.999 99). The limit of detection was 8.25 ng. The average recovery was 99.71% with RSD of 0.30%. Conclusion With good accuracy and precision, this method can be used for the determination of atropine sulfate and related substances in Atropine Sulfate Eye Drops.