Quality assessment and stability study of compounded furosemide syrup

Authors

DOI:

https://doi.org/10.15587/2519-4852.2017.113517

Keywords:

furosemide, syrup, compounded preparations, in-pharmacy control, stability, quality assessment, thin layer chromatography

Abstract

Compounded oral preparations, made with use of manufactured products as sources of active pharmaceutical ingredients, are characterized by short beyond-use-dates due to their instability.

Aim: The aim of this study is to investigate the physical, chemical and microbiological stability of compounded furosemide syrups within a 30 days period.

Methods: Batches of 5 mg/ml compounded syrups, using furosemide substance and commercial tablets (two brands) as sources of active pharmaceutical ingredients, were stored in the dark at 5±3 °C and 23±2 °C and examined at days 0, 7, 15, 23, and 30 for changes in physical (pH, formation of colour, gas, odour and changes in viscosity), chemical and microbial stability. A stress test was conducted in order to distinguish signs of chemical instability using a stability-indicating thin-layer chromatographic method. Bacterial inoculation of these samples were examined for microbial stability based on the total aerobic microbial count (TAMC <100), the total combined yeasts/moulds count (TYMC <10) and absence of Escherichia coli.

Results: Throughout the storage period the investigated syrups showed no extra spots on the chromatogram, no significant changes in pH, colour, odour, gas formation, viscosity. On day 30, the content (≥99.3%) of furosemide, total aerobic microbial count (< 102), total combined yeasts/moulds count (<101) in studied samples were within acceptable limits. Stressed samples showed presence of extra and diminished spots.

Conclusions: Extemporaneous syrups of furosemide substance and dispersed furosemide tablets, stored in glass bottles in the dark at 5±3 °C and 23±2 °C, was found to be physically, chemically and microbiologically stable for at least 30 days

Author Biographies

Deghinmotei Alfred-Ugbenbo, National University of Pharmacy Pushkinska str., 53, Kharkіv, Ukraine, 61002

Postgraduate student

Department of Pharmaceutical chemistry 

Oleksandr Zdoryk, National University of Pharmacy Pushkinska str., 53, Kharkіv, Ukraine, 61002

PhD, Associate professor

Department of Pharmaceutical chemistry 

Viktoria Georgiyants, National University of Pharmacy Pushkinska str., 53, Kharkіv, Ukraine, 61002

Doctor of pharmaceutical sciences, Professor, Head of department

Department of Pharmaceutical chemistry 

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Published

2017-10-31

How to Cite

Alfred-Ugbenbo, D., Zdoryk, O., & Georgiyants, V. (2017). Quality assessment and stability study of compounded furosemide syrup. ScienceRise: Pharmaceutical Science, (5 (9), 28–35. https://doi.org/10.15587/2519-4852.2017.113517

Issue

No. 5 (9) (2017)

Section

Pharmaceutical Science

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Copyright (c) 2017 Deghinmotei Alfred-Ugbenbo, Oleksandr Zdoryk, Viktoria Georgiyants

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