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)(42:58,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.
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 .
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.
ABSTRACT
The goal of the present investigation was to design and evaluate mucoadhesive buccal patches of Cyproheptadine Hydrochloride (CPH) which is a sedating antihistamine with antimuscarinic, serotonin-antagonist, and calcium-channel blocking action. Buccal films were made with Hydroxy propylcellulose (HPC EF) and Hydroxy Propyl Methyl Cellulose (HPMC E15) as mucoadhesive polymers. Permeation of CPH was calculated ex vivo using porcine buccal membrane. The patches were evaluated for weight variation, thickness variation, surface pH, moisture absorption, in vitro residence time, mechanical properties, in vitro release, ex vivo permeation studies and drug content uniformity. The formulation F8 of HPMC E15 was found to give the better results and release of drug from the film followed Higuchi and Korsmeyer and Peppas models.
ABSTRACT
OBJECTIVE:To establish a method for content determination of cyproheptadine hydrochloride in fuyan cream.METHODS:Ultraviolet spectophotometry was applied to determine the contents of cyprohepatadine hydrochloride as well as its adjuvant as two coexisting components without isolation and extraction,the wavelengths were286nm and258nm res_ pectively,linear regression and simultaneous equations were used to analyze the results.RESULTS:Cyproheptadine hydrochlor_ ide and its adjuvant showed good linear relationship in the range of2.52～25.2and2.5022～25.022?g/ml respectively,the average recovery of cyproheptadine hydrochloride was98.61%(RSD=1.08%).CONCLUSION:The present method is simple,convenient,reproducible and reliable,which is suitable for rapid determination for fuyan cream.