Investigation of the cyproheptadine by chromatographic methods

O. O. Mamina, V. I. Kabachny

Abstract


Topicality. Cyproheptadine hydrochloride (peritol) is an antihistaminic drug with an antiserotonin effect, which prevents development and facilitates the course of allergic reactions. The drug is characterized by antipruritic, antiexudative, anticholinergic and sedative effects. According to the literature sources, the drug can cause intoxication of the body and the lethal effects of overdosing, self-medication and in cases of suicide. The elaboration of highly sensitive and selective methods for the study of cyproheptadine, suitable for analysis in biological objects is an actual task.

Aim. To study the elaboration of algorithm for the directed analysis of cyproheptadine in biological extracts by HPLC and TLC methods.

Materials and methods. TLC studies were performed using 16 mobile solvent systems and three types of chromatographic plates. To identify the cyproheptadine were applied universally visualization conditions. HPLC studies were performed on a microcolumn liquid chromatograph “Milichrom A-02” (RPA “EkoNova” Novosibirsk, Russia) in a reversed-phase variant using a metal column with a non-polar sorbent Prontosil 120-5C 18 AQ.

Results and discussion. TLC conditions for purifying cyproheptadine from biogenic impurities and its identification have been established. Based on the results of the studies, the behavior of cyproheptadine by the HPLC method was studied. Identification was carried out using retention parameters, spectral relationships, and quantitative determination using the absolute calibration method. The method is validated by parameters – range of linearity, limit of detection and quantitative determination, accuracy and precision.

Conclusions. It was established that the most suitable TLC conditions for CTA of cyproheptadine are: mobile solvent systems – ethyl acetate-methanol-25 % solution ammonium hydroxide (85 : 10 : 5), glass plates of firm “Merk” (Rfcyproheptadine = 0.50-0.55) and methanol, methanol-n-buthanol (60 : 40), Sorbphil-PTCX-AF-A (Rfcyproheptadine = 0.55-0.58). It is established that the HPLC-method may determine cyproheptadine in a concentration range of 10.0-200.0 µg/ml. The relative uncertainty of the average result is ± 2.05 %. An algorithm for the direct analysis of cyproheptadine in biological extracts by HPLC and TLC methods has been developed.


Keywords


cyproheptadine hydrochloride (peritol); identification; quantitation; HPLC (high performance liquid chromatography); TLC (thin layer chromatography)

References


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DOI: https://doi.org/10.24959/ubphj.17.124

Abbreviated key title: Ukr. bìofarm. ž.

ISSN 2519-8750 (Online), ISSN 2311-715X (Print)