Determination of Content and Related Substances of Cyproheptadine Hydyochloride Tablets by HPLC / 中国药师

ABSTRACT

Objective:To establish a determination method for the content of cyproheptadine hydyochloride tablets and the related substances in the tablets by HPLC. Methods:The assay was performed on a CAPCELL PAK C18(Shiseido)(250 mm ×4.6 mm, 5μm) column with methanol-0. 002 5mol·L-1 sodium heptanesulfonate (adjusting pH to 3 with phosphoric acid)(60 40) as the mo-bile phase. The detection wavelength was 225 nm, the flow rate was 1. 0 ml·min-1 , the column temperature was 30℃ and the sample size was 10 μl. Results: Cyproheptadine hydyochloride had good linear relationship within the range of 4. 12-82. 40 μg·ml-1 ( r=1. 000 0), and the average recovery was 99. 2%(RSD=0. 8%, n=9). The peaks of the related substances were well separated from that of cyproheptadine hydrochloride. Conclusion:The method is simple, fast and accurate, and can be used for the quality control of cyproheptadine hydyochloride tablets.