Selection and verification of the method for phynelefrine hydrochloride assay in Simanovsky ointment

Abstract

Phenylephrine hydrochloride is a sympathomimetic with expressed local vasoconstrictor effect. Its ability to reduce swelling and hyperemia of the nasal mucosa is used in the Simanovsky ointment which is preparing for stock in the pharmacies of Ukraine. For the assay of phenylephrine hydrochloride in many single and multicomponent dosage forms, it is suggested to use a spectrophotometric method. However, in literary sources there are no examples of the use of spectrophotometric method for quantitative determination of phenylephrine hydrochloride in the studied ointment. Aim. The purpose of the research was to select and verify the optimal method for phenylephrine hydrochloride assay in the Simanovsky ointment with the possibility of its further use for the stability analysis of the dosage form during storage. Methods. Direct UV-spectrophotometry method for assay of phenylephrine hydrochloride in the studied ointment. Results. For the quantitative determination of phenylephrine hydrochloride in the Simanovsky ointment, the method of direct spectrophotometry was selected after its extraction from the ointment base with 0.1 M hydrochloric acid. In order to prove the possibility of its use in the ointment analysis, the determination of the validation characteristics was made. The obtained results indicate that the requirements for the specificity of the method (δ noise , %=0.47≤1.02), the parameters of linear dependence, the accuracy (δ,%=0.20≤1.02) and the precision (ΔZ=0.39≤3.20) are met. The study of the robustness of the technique shows the stability of solutions within an hour. The method was tested on the researched ointment. The metrological characteristics of methods for calculating the quantitative content of phenylephrine hydrochloride by the standard method and specific absorption index were determined. The obtained results indicate the possibility of using both methods. Conclusions. For the assay of phenylephrine hydrochloride in the Simanovsky ointment, the method of direct spectrophotometry was chosen. Validation characteristics of the method indicate the possibility of its use for medicine analysis and study of its stability during storage. It was proved that the calculation of the quantitative content of phenylephrine hydrochloride in the ointment can be carried out using both the standard method and the method of specific absorption index