Determination of drug content and related substances in cyproheptadine hydrochloride injection by HPLC / 国际药学研究杂志

ABSTRACT

Objective: To establish a high performance liquid chromatography(HPLC)method for the determi- nation of drug content and related substances in cyproheptadine hydrochloride injection. Methods: COSMOSIL C8 col- umn(4.6 mm×250 mm,5 μm)was used for the determination of drug content. The mobile phase was acetonitrile-phos- phate buffer(0.045 mol/L,adjusted to pH 4.5 with phosphoric acid)(4258,V/V). The flow rate was 1.0 ml/min. Injec- tion volume was 20 μl. The detection wavelength was 286 nm. By reference to Chinese Pharmacopoeia 2015,the deter- mination of related substances was also carried out by the HPLC method under the same conditions as the drug content determination except for the gradient elution and the detection wavelength(set at 230). Using these established HPLC methods,the drug content was determined for the three batches of self-made cyproheptadine hydrochloride injection samples and the stability of the injection was also investigated. Results: The calibration curve of cyproheptadine hydrochlo- ride was linear in the range of 10-40 μg/ml(Y=40.551X+13.869,r=0.9999). The average recovery was 99.00%(RSD= 0.39%). Under the HPLC condition,cyproheptadine hydrochloride and its related substances were completely separated and the excipients did not interfere with their determination. Conclusion: The established HPLC method is simple,ac- curate,sensitive and specific,which could be used for the determination of drug content and related substances in the cy- proheptadine hydrochloride injection.