Abstract
A simple, sensitive and reproducible reversed phase ultra performance liquid chromatography (RP-UPLC) coupled with a photodiode array detector method was developed for the quantitative determination of metaxalone (META) in pharmaceutical dosage forms. The method is applicable to the quantification of related substances and assay of drug product. Chromatographic separation was achieved on an Acquity® HSS-T3 (100 mm x 2.1 mm, 1.7 μm) column. The optimized isocratic mobile phase consists of a mixture of water, methanol, acetonitrile and triethylamine in the ratio of 50:25:25:0.1 % v/v (pH adjusted to 6.3 with orthophosphoric acid). The eluted compounds were monitored at 230 nm for META assay and 205 nm for related substances, the flow rate was 0.3 mL/min, and the column oven temperature was maintained at 45°C. The developed method separated META from its two known and two unknown impurities within 6.0 min. Metaxalone was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Metaxalone was found to degrade significantly in base stress condition, degrade slightly in oxidative stress condition and remain stable in acid, hydrolytic, thermal and photolytic degradation conditions. All impurities were well resolved from each other and from the main peak, showing the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines.
Highlights
Metaxalone, chemically 5-[(3,5-dimethylphenoxy)methyl]-1,3-oxazolidin-2-one, was first synthesized by Lunsford, et al [1]
Very few methods have appeared in the literature for the assay determination of META in bulk and pharmaceutical dosage forms by high-performance liquid chromatography (HPLC) [10,11,12]
Method development and optimization The main objective of the reversed phase ultra performance liquid chromatography (RP-UPLC) method development was the finding of a rapid assay and related substances determination of Metaxalone in pharmaceutical formulation were: the method should be able to determine assay (AS) and related substances (RS) in single run and should be accurate, reproducible, robust, stability-indicating, filter compatible, linear, free of interference from blank / placebo / impurities / degradation products and straightforward enough for routine use in quality control laboratory
Summary
Metaxalone, chemically 5-[(3,5-dimethylphenoxy)methyl]-1,3-oxazolidin-2-one, was first synthesized by Lunsford, et al [1]. This technology has been applied to the method development and method validation study of related substances and the assay determination of Metaxalone in pharmaceutical dosage forms. A reproducible stability-indicating RP-UPLC method was developed for the quantitative determination of META and its two known impurities (Imp-A and Imp-B), this developed proposed method is able to separate two unknown degradation products from interested compounds within 6.0 min.
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