Development and validation of spectrophotometric determination of propranolol in extemporaneous powders of manufacture for children
- Authors: Abdullina S.G.1, Kropacheva D.O.1
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Affiliations:
- Kazan State Medical University
- Issue: Vol 28, No 1 (2025)
- Pages: 41-47
- Section: Pharmaceutical chemistry
- URL: https://ogarev-online.ru/1560-9596/article/view/278995
- DOI: https://doi.org/10.29296/25877313-2025-01-05
- ID: 278995
Cite item
Abstract
Introduction. Propranolol, a non-selective beta-blocker, is included in Russian and international treatment protocols for various cardiovascular diseases 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 required. 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 dextrose 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 cuvettes 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 lactose. The validation of the method was carried out by the requirements of OFS.1.1.0012 “Validation of analytical methods” of the Russian State Pharmacopoeia 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 lactose has been developed and carried out. The proposed method can be used to control the quality of extemporal medicines.
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##article.viewOnOriginalSite##About the authors
S. G. Abdullina
Kazan State Medical University
Author for correspondence.
Email: svetlana.abdullina@kazangmu.ru
ORCID iD: 0000-0002-4049-1903
Dr.Sc. (Pharm.), Professor
Russian Federation, 49 Butlerova street, Kazan, 420012D. O. Kropacheva
Kazan State Medical University
Email: svetlana.abdullina@kazangmu.ru
ORCID iD: 0009-0008-7536-1288
Post-graduate Student
Russian Federation, 49 Butlerova street, Kazan, 420012References
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