DETERMINATION OF DOXORUBICIN HYDROCHLORIDE IN PHARMACEUTICA DOSAGE FORMS BY A SIMPLE STABILITY-INDICATING MICELLAR ELECTROKINETIC CAPILLARY CHROMATOGRAPHY METHOD

Authors

  • Daniele Rubert Nogueira-Librelotto Universidade Federal de Santa Maria
  • Laís Engroff Scheeren Universidade Federal de Santa Maria
  • Clarice Madalena Bueno Rolim Universidade Federal de Santa Maria
  • Letícia Bueno Macedo Universidade Federal de Santa Maria
  • Joana Rodrigues Fernandes Universidade Federal de Santa Maria

DOI:

https://doi.org/10.22456/2527-2616.91896

Abstract

A stability-indicating micellar electrokinetic capillary chromatography (MEKC) method was developed and validated for the analysis of doxorubicin hydrochloride in injectable pharmaceutical dosage forms, using methotrexate as internal standard. A fused-silica capillary (50 µm i.d.; effective length, 40 cm) and a running electrolyte solution consisting of 10 mM borate buffer and 20 mM anionic surfactant SDS, at pH 9.3, were set as the best experimental conditions. Moreover, the capillary temperature was maintained at 26 ºC, while the applied voltage was +26 kV. Hydrodynamic sample injection (6 s at 50 mbar) was used, and the detection was set at 260 nm using a photodiode array detector. The method was validated for the requirements specificity, linearity, precision, accuracy, and robustness, following the International Conference on Harmonisation (ICH) guidelines. The method linearity was proven in the range of 25-125 µg/mL (r = 0.9995). Forced degradation studies were successfully conducted, evidencing the specificity and stability-indicating capability of the method. In addition, no interference of the excipients from the formulation was detected. The values of accuracy and precision were within the acceptable limits, and robustness studies were performed by a two-level full factorial design. The proposed method fulfilled all validation parameters and was shown to be suitable for quantitative analyses of doxorubicin, contributing, thus, to the establishment of new alternatives with advantages for the quality control of pharmaceutical formulations.

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Author Biographies

Daniele Rubert Nogueira-Librelotto, Universidade Federal de Santa Maria

Department of Industrial Pharmacy

Laís Engroff Scheeren, Universidade Federal de Santa Maria

Department of Industrial Pharmacy

Clarice Madalena Bueno Rolim, Universidade Federal de Santa Maria

Department of Industrial Pharmacy

Letícia Bueno Macedo, Universidade Federal de Santa Maria

Department of Industrial Pharmacy

Joana Rodrigues Fernandes, Universidade Federal de Santa Maria

Department of Industrial Pharmacy

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Published

2019-07-17

How to Cite

Rubert Nogueira-Librelotto, D., Engroff Scheeren, L., Bueno Rolim, C. M., Bueno Macedo, L., & Rodrigues Fernandes, J. (2019). DETERMINATION OF DOXORUBICIN HYDROCHLORIDE IN PHARMACEUTICA DOSAGE FORMS BY A SIMPLE STABILITY-INDICATING MICELLAR ELECTROKINETIC CAPILLARY CHROMATOGRAPHY METHOD. Drug Analytical Research, 3(1), 29–35. https://doi.org/10.22456/2527-2616.91896

Issue

Section

ORIGINAL ARTICLES