A spectrophotometric method for the quantitative determination of propranolol in extemporaneous powders with dextrose or lactose was developed and validated, showing linearity from 12 to 28 µg/mL and a relative standard deviation under 2.0%.
A validated spectrophotometric method allows for quality control of extemporaneous propranolol powders used for pediatric dosing.
Introduction. Propranolol, a non-selective beta-blocker, is included in Russian and international treatment protocols for various cardiovascular diseas-es in children and adults. It has also demonstrated efficacy in the treatment of infantile hemangiomas, migraines, glaucoma and other diseases. The pharmaceutical industry produces propranolol in tablets of 10 and 40 mg. However, for pediatric treatment, dosages of 0.5–2.5 mg/kg/day are re-quired. Extemporaneous pharmaceutical powders for internal use allow for individual dosing. This study aims were to develop method for the quantitative determination of propranolol by spectrophotometric method in powders containing dex-trose or lactose and to carry out validation assessment of this method. Material and methods. The pharmaceutical substances propranolol hydrochloride was purchased from (Changzhou Yabang Pharmaceutical Co., Ltd, China), dextrose monohydrate – from (Weifang Shengtai Medicine Co., Ltd, China) and lactose monohydrate – from (DFE Pharma GmbH&Co. KG, Goch, Germany). The optical density of propranolol solutions was measured on a UNICO 2802 spectrophotometer (Russia) at a wavelength of 290 nm in cu-vettes with a layer thickness of 10 mm. Weighing of the samples was carried out on an analytical balance ADV-200M (Russia). Results. The method has been developed for the spectrophotometric quantitative determination of propranolol in powders containing dextrose or lac-tose. The validation of the method was carried out by the requirements of OFS.1.1.0012 “Validation of analytical methods” of the Russian State Phar-macopoeia of the XV edition, confirmed its specificity, linearity in the range from 12 to 28 µg/mL (r=0,9995 for dextrose powder и r=0,9997 for lactose powder), intermediate (intra-laboratory) precision and accuracy. The results are not burdened by systematic error. The relative standard deviation (RSD) does not exceed 2.0%. Conclusions. A validation evaluation of a spectrophotometric method for the quantitative determination of propranolol in powders with dextrose or lac-tose has been developed and carried out. The proposed method can be used to control the quality of extemporal medicines.
Абдуллина et al. (Tue,) reported a other. Spectrophotometric method for quantitative determination of propranolol was evaluated on Validation of the spectrophotometric method (linearity, precision, accuracy). A spectrophotometric method for the quantitative determination of propranolol in extemporaneous powders with dextrose or lactose was developed and validated, showing linearity from 12 to 28 µg/mL and a relative standard deviation under 2.0%.