VALIDATION OF ANALYTICAL METHODOLOGY FOR THE QUANTITATIVE DETERMINATION OF ATENOLOL IN PHARMACY POWDERS FOR CHILDREN

Atenolol is a cardioselective β1-adrenoblocker with hypotensive, antianginal and antiarrhythmic effects. In paediatric practice, it is used for the treatment of heart defects and infantile haemangiomas, showing, compared to propranolol, fewer side effects from the central nervous system and bronchi. The pharmaceutical industry produces atenolol in 25, 50 or 100 mg tablets, while the most commonly used therapeutic dose of atenolol for the treatment of infants and young children is 0.5-1.5 mg/kg/day. The problem of atenolol dosing is solved by extemporaneous formulation. Doctors prescribe atenolol in the form of powder with dextrose or lactose. Extemporaneous manufacture allows maximum adaptation of the dosage to the needs of newborns and young children. A unified technique for quantitative determination of atenolol in powders with dextrose or lactose by spectrophotometric method was developed. The optical density of solutions was measured at a wavelength of 275 nm in cuvettes with a layer thickness of 10 mm. A 0.1 M solution of hydrochloric acid was used as a reference solution for standard solutions of atenolol and model powder solutions with dextrose; for model powder solutions with lactose, a reference solution containing 0.1 g of lactose in 100 ml of 0.1 M solution of hydrochloric acid was used. The experimental results are not burdened with systematic error. The relative standard deviation does not exceed 0.5%, the relative error of the mean does not exceed 0.4%. The proposed methodology is valid in terms of specificity, linearity and analytical scope of the methodology, intermediate (intra-laboratory) precision and correctness. The methods can be used in the practice of manufacturing pharmacies to assess the parameter ‘Quantitative Determination’.