Stability-Indicating Spectrophotometric Methods for Determination of Milnacipran HCl and Duloxetine HCl in Bulk Drug and Pharmaceutical Formulations
Maha F. Abdel-Ghany; Omar Abdel-Aziza; Nermine Victor Fares; Eman W. E. Farag;
Abstract
The present study describes accurate and sensitive stability-indicating spectrophotometric methods for the
determination of Milnacipran HCl in presence of its acid, base degradates, and Duloxetine HCl in
presence of its base degradates; including Dual-wavelength, Ratio difference, and Ratio derivative
techniques. The developed methods were validated according to the International Conference on
Harmonisation (ICH) guidelines. The recovery percentage of Milnacipran HCl and Duloxetine HCl were
found to be in the ranges 99.42-100.42% and 100.17-100.3%, respectively. The low relative standard
deviation of precision results confirms the suitability of the proposed methods for the estimation of the
studied drugs in pure form, laboratory-prepared mixtures, and pharmaceutical formulations. Statistical
comparison of the proposed methods with the reported methods revealed that there were no significant
differences concerning the accuracy and precision of the adopted techniques. Validation studies
demonstrated that the proposed methods are easy, specific, and rapid for the determination of Milnacipran
HCl and Duloxetine HCl.
determination of Milnacipran HCl in presence of its acid, base degradates, and Duloxetine HCl in
presence of its base degradates; including Dual-wavelength, Ratio difference, and Ratio derivative
techniques. The developed methods were validated according to the International Conference on
Harmonisation (ICH) guidelines. The recovery percentage of Milnacipran HCl and Duloxetine HCl were
found to be in the ranges 99.42-100.42% and 100.17-100.3%, respectively. The low relative standard
deviation of precision results confirms the suitability of the proposed methods for the estimation of the
studied drugs in pure form, laboratory-prepared mixtures, and pharmaceutical formulations. Statistical
comparison of the proposed methods with the reported methods revealed that there were no significant
differences concerning the accuracy and precision of the adopted techniques. Validation studies
demonstrated that the proposed methods are easy, specific, and rapid for the determination of Milnacipran
HCl and Duloxetine HCl.
Other data
Title | Stability-Indicating Spectrophotometric Methods for Determination of Milnacipran HCl and Duloxetine HCl in Bulk Drug and Pharmaceutical Formulations | Authors | Maha F. Abdel-Ghany; Omar Abdel-Aziza; Nermine Victor Fares ; Eman W. E. Farag | Issue Date | 2019 | Publisher | Ain Shams University, Faculty of Pharmacy | Journal | Archives of Pharmaceutical Science Ain Shams University | Volume | 3 | Issue | 2 | Start page | 246 | End page | 267 | DOI | 10.21608/APS.2019.13058.1005 |
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