SPECTROPHOTOMETRIC DETERMINATION OF NITROFURAL IN A MULTICOMPONENT SPRAY
DOI:
https://doi.org/10.11603/2312-0967.2023.4.14295Keywords:
nitrofural, pharmaceutical spray, spectrophotometry, quantitative determinationAbstract
The aim of the work. Development of spectrophotometric methods for the quantitative determination of nitrofural in a multicomponent nasal spray of antihistamine action of extemporaneous manufacture.
Materials and Methods. Extemporaneous dosage form was chosen as the material for the study: "Allergy Spray" (manufactured by Leda LLC, Kharkiv). The model mixtures were prepared using the substances nitrofural, diphenhydramine hydrochloride, phenylephrine hydrochloride and sodium chloride, which were used in the manufacture of the dosage form with the appropriate quality certificates. The study was carried out using an AXIS analytical balance (Poland), a SHIMADZU UV-2600 spectrophotometer, a pH meter (pH-150 MI), class A measuring utensils and reagents that meet the requirements of the State Pharmacopoeia of Ukraine (SPU).
Results and Discussion. Two simple, specific, easy, correct and precise spectrophotometric methods were first developed for the study of nitrofural in combination, without prior separation of the components of the spray under study. It is proposed to use the method of absorption spectrophotometry in the ultraviolet region in aqueous medium based on the intrinsic absorption of the compound at 375 nm and the method of absorption spectrophotometry in the visible region in the medium of 0.1 M sodium hydroxide solution at a wavelength of 445 nm.
The obedience to the basic law of light absorption of nitrofural solutions in both media is observed within the concentration of the compound from 0.0016 mg/ml to 0.0160 mg/ml. The obtained validation characteristics indicate that the proposed spectrophotometric methods for the quantitative determination of nitrofural in the studied multicomponent dosage form meet the parameters of correctness, accuracy, linearity (=1.60 ≤ max=3.20, d=0.33% and 0.09 ≤ maxd = 1.02, a=0.04 and 1.38 max a=5.12, r = 0.9999 min r=0.9924).
Conclusions. Develop the spectrophotometric methods for the determination of nitrofural in a combination drug product in the form of a spray. It has been proved that the proposed spectrophotometric methods for the quantitative determination of nitrofural in a multicomponent drug product are valid in terms of such validation characteristics as linearity, precision, accuracy and robustness.
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