Abstract
DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING AND LCMS COMPATIBLE UPLC METHOD FOR ESTIMATION OF ASSAY, RELATED SUBSTANCES AND DEGRADANTS IN DEXTROMETHORPHAN HYDROBROMIDE ACTIVE PHARMACEUTICAL INGREDIENT.

Umamaheshwar Puppala*, Koduri S. V. Srinivas, K. Venkateshwara Reddy and Bhaskara Rao Jogi

ABSTRACT

The current study reports the sensitive and reproducible stability indicating ultra performance liquid chromatography method for quantitative determination of Dextromethorphan Hydrobromide assay and its related substances including process related impurities and degradation products. The drug was subjected to various stress conditions such as hydrolysis, oxidation, photo- and thermal degradations to investigate the stability indicating ability of the method. Significant degradation was observed during oxidative stress. Dextromethorphan Hydrobromide was well resolved from its process related impurities and degradation products formed under stress conditions. Efficient chromatographic separation was achieved on an Acquity; UPLC, BEH; C-18;100 X 2.1mm; 1.7 μm column with the mobile phase consisting of 10mm Ammonium bicarbonate in water and CH3CN/Methanol in a gradient elution mode within a short run time of 13 minutes at a flow rate of 0.3 ml/min. The eluents were monitored by a photodiode array detector at 225 nm and quantitation limits were obtained in the range of 0.1–1.0 μg ml-1 for Dextromethorphan Hydrobromide and all its process related impurities. The resolution between DHB and its seven impurities was greater than 2.5 for all pairs of impurities. The developed UPLC method is superior in technology against conventional HPLC with respect to speed, resolution, solvent consumption and cost of analysis. This method is compatible to LCMS analysis which enables to identify the unknown impurities formed in the process. The developed liquid chromatographic UPLC method was validated as per the ICH guidelines.

Keywords: Dextromethorphan Hydrobromide (DHB), UPLC, process related impurities, stability indicating method.


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