Abstract
A sensitive, stability-indicating gradient RP-HPLC method has been developed for the simultaneous estimation of impurities of Guaifenesin and Dextromethorphan in pharmaceutical formulations. Efficient chromatographic separation was achieved on a Sunfire C18, 250 × 4.6 mm, 5 µm column with mobile phase containing a gradient mixture of solvents A and B. The flow rate of the mobile phase was 0.8 mL min−1 with column temperature of 50°C and detection wavelength at 224 nm. Regression analysis showed an r value (correlation coefficient) greater than 0.999 for Guaifenesin, Dextromethorphan, and their impurities. Guaifenesin and Dextromethorphan formulation sample was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Guaifenesin was found stable and Dextromethorphan was found to degrade significantly in peroxide stress condition. The degradation products were well resolved from Guaifenesin, Dextromethorphan, and their impurities. The peak purity test results confirmed that the Guaifenesin and Dextromethorphan peak was homogenous and pure in all stress samples and the mass balance was found to be more than 98%, thus proving the stability-indicating power of the method. The developed method was validated according to ICH guidelines with respect to specificity, linearity, limits of detection and quantification, accuracy, precision, and robustness.
Highlights
Guaifenesin (GN), (+)-3-(2-methoxyphenoxy)-propane-1,2diol, is a widely used expectorant, useful for the symptomatic relief of respiratory conditions
Its empirical formula is C10H14O4, which corresponds to a molecular weight of 198.21
Its empirical formula is C8H25NO, which corresponds to a molecular weight of 271.4
Summary
Guaifenesin (GN), (+)-3-(2-methoxyphenoxy)-propane-1,2diol, is a widely used expectorant, useful for the symptomatic relief of respiratory conditions. The presence of unwanted or in certain cases unknown chemicals, even in small amounts, may influence the therapeutic efficacy and the safety of the pharmaceutical products [9] For these reasons, all major international pharmacopoeias. There were several LC assay methods that have been reported for the determination of GN and DN in pharmaceutical preparation either individually or in combination with other drugs [12,13,14,15,16,17,18,19,20] and in human plasma by LC-MS [21, 22]. It is felt to develop a stability-indicating method for simultaneous determination of GN and DN related impurities in pharmaceutical formulation. The stability tests were performed on both drug substances and drug products as per ICH norms [25, 26]
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