Validation of analytical methods for quality control and stability study of the ephedrine nasal drops

Authors

  • Niurka Benítez Laboratorio Farmacéutico Líquidos Orales Bayamo (MEDILIP)
  • Juan Manuel Cordoví Laboratorio Farmacéutico Líquidos Orales Bayamo (MEDILIP)
  • Mirna Fernández Instituto de Farmacia y Alimentos (IFAL)
  • Reynerio Zamora Laboratorio Farmacéutico Líquidos Orales Bayamo (MEDILIP)
  • Nilia de la Paz Centro de Investigación y Desarrollo de Medicamentos (CIDEM)
  • Pavel Cabrera Laboratorio Farmacéutico Líquidos Orales Bayamo (MEDILIP)

Keywords:

Clorhidrato de efedrina, Estudios de validación, Gotas nasales, Método cromatográfico.

Abstract

Aims: The purpose of this study was to validate three analytical methods for quality control and stability study of nasal drops ephedrine hydrochloride.

Materials and methods: A liquid chromatographic technique was developed for the quantification of ephedrine hydrochloride and two volumetric techniques for quantification of benzalkonium chloride and edetate disodium, preservatives in the formulation. The evaluated parameters were consistent with internationally established quantitative techniques such as specificity, linearity, accuracy, precision, robustness and limits of detection and quantification.

Results: It was demonstrated that the chromatographic method was linear, with a detection limit of 2.62 μg/mL and 5.56 μg/mL as LOQ, selective, accurate, precise and robust. The volumetric method for the benzalkonium chloride was linear, with a detection limit of 0.60 μg/mL and 2.24 μg/mL as the limit of quantification, specific, accurate, precise and robust. The results of the performance evaluation of volumetric method for disodium edetate demonstrated their precision, accuracy and specificity.

Conclusions: The chromatographic method for the determination of the active as well as volumetric methods for the quantification of preservatives in the formulation met all the parameters evaluated in the validation, being useful for quality control and stability study.

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References

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Published

2014-09-20

How to Cite

1.
Benítez N, Cordoví JM, Fernández M, Zamora R, de la Paz N, Cabrera P. Validation of analytical methods for quality control and stability study of the ephedrine nasal drops. Ars Pharm [Internet]. 2014 Sep. 20 [cited 2024 Jul. 22];55(3):11-8. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/4496

Issue

Vol. 55 No. 3 (2014)

Section

Original Articles

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