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.
Highlights
Fibromyalgia means “muscle and connective tissue pain" derived from new Latin, fibro, meaning "fibrous tissues", Greek myo, "muscle", and Greek algos, "pain" [1].Fibromyalgia is an idiopathic, chronic, nonarticular pain syndrome, which commonly begins after a physical trauma, surgery, infection or significant psychological stress [2].The widespread occurrence of fibromyalgia is common in the female gender and increasing age
Each of these solutions was measured in triplicate in the wavelength range from 240 nm to 300 nm. Each of these spectra was divided by acid-induced degradation of Milnacipran HCl (10 μg/mL) as a divisor to get the corresponding ratio spectra
Approaches based on the standard deviation of the intercept and the slope were used for determining the Limit of Detection (LOD) and Limit of Quantitation (LOQ), where
Summary
Fibromyalgia means “muscle and connective tissue pain" derived from new Latin, fibro-, meaning "fibrous tissues", Greek myo, "muscle", and Greek algos, "pain" [1]. Both the antidepressant activities and pain inhibitory properties of duloxetine are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS, the exact mechanisms in humans are unknown [4]. Milnacipran is a serotonin-norepinephrine reuptake inhibitor in a ratio of 1:3 Treatment of both depression and fibromyalgia is achieved by increasing both neurotransmitters concentration simultaneously [5]. The proposed methods are considered the first spectrophotometric methods for the determination of Milnacipran and Duloxetine in presence of their degradation products by utilizing dual-wavelength [19], ratio difference [20], and ratio derivative [21, 22] techniques. The scientific novelty of the developed methods is that they were found to be easier, more rapid, less expensive and less time-consuming than the sophisticated HPLC methods for the determination of the studied drugs
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