Assay of cyproheptadine hydrochloride and the related substances with HPLC / 药学实践杂志

ABSTRACT

Objective To establish a HPLC method for the assay of cyproheptadine hydrochloride and the related sub-stances.Methods TheHPLCwasperformedonanAgilentEclipseXDB-C18column(4.6mm×250mm,5μm)atthetemper-ature of 25 ℃ with the mobile phase of acetonitrile-buffer Solution ( Dissolve 2 .16 g of sodium octane-1-sulfonate with about 500 ml of water and mix well .Add 10 .0 ml of glacial acetic acid and 5 .0 ml of triethylamine ,and dilute with water to 1 000 ml ,mix well and adjust to pH 7 .0 with triethylamine) (85∶15 ,V/V ) .The flow rate was 1 .0 ml/min and detection wavelength was 286 nm .The injection volume was 10μl .Results The calibration curves of cyproheptadine hydrochloride ,im-purity A ,B and C showed good linear response in the range from 0 .056 2 to 5 .620 μg/ml (r= 0 .999 8) ,0 .052 4 to 5 .240 μg/ml(r=1 .000 0) ,0 .050 3 to 5 .032 μg/ml (r=0 .999 9) and 0 .053 2 to 5 .316 μg/ml(r=0 .999 8) respectively .The LOQs for cyproheptadine hydrochloride ,impurity A ,B and C were within 0 .049-0 .054 μg/ml ,LODs were within 0 .019-0 .022 μg/ml with recovery between 98%-100% .RSD of repeatability was 5 .5% (n=6) .Conclusion This method gave an accurate and reliable results .It can be used for quality control of cyproheptadine hydrochloride .