Possible benefits of evaluation the coefficient of variation of active substance of a drug from different manufactures based on benzydamine hydrochloride example

Abstract

Acute respiratory viral infection (ARVI) is one of the most common causes of morbidity in Russia. The incidence rate is high regardless of age or social group [1]. Sore throat is the most common symptom during ARVI, prevalence rate is 95%[2]. Symptomatic treatment of ARVI requires the use of various drugs, including drugs for pain in the throat. Such preparations are widely represented on the market, while they have a different form and different composition. One of the most popular are sprays containing benzydamine hydrochloride. Professional associations recommend using Benzydamine hydrochloridewhile sore throat, also in paediatric practice [3].In connection with a large number of generics, the issue of standardization of such sprays is topical. To compare the range of the actual concentration of the active substance in interchangeable preparations with different trade names, a comparative determination of the concentrations of benzydamine hydrochloride in sprays of 4 trade names was carried out in 6 different series in each. The quantitative determination was carried out by HPLC with a UV detector. As a result, the active substance concentration ranges were determined in 6 batches of the preparation of each trade name, and the coefficient of variation of concentrations was calculated and conclusions were made on the difference in the indicated indices among preparations of various manufacturers.