An Ultra Performance Liquid Chromatographic Method Validation of Guaifenesin and Hydrocodone Bitrartrate

Abstract

Objective: This investigation demonstrates a stability-indicating and reliable “reverse phase high-performance liquid chromatography” method to simultaneously quantify Hydrocodone Bitartrate and Guaifenesin in the pharmaceutical dosage form.

Methods: Successful separation was accomplished using Agilent C₁₈ column (150 mm x 4.6 mm, 3.5μm) with isocratic type of elution using mobile phase containing Acetonitrile + 0.1% Ortho Phosphoric acid buffer (50:50) respectively with 1 ml/min flow rate. The wavelength sensor was attuned at 247 nm to quantify Hydrocodone Bitartrate and Guaifenesin.

Results: Guaifenesin and Hydrocodone Bitartrate peaks were eluted with fine resolution at retention times 2.729 min and 4.127 min respectively. In 20-120 μg/ml concentration range for Guaifenesin and 0.25-1.5 μg/ml Hydrocodone Bitartrate, the calibration graphs were linear, with regression coefficients of 0.9998 and 0.9998 respectively. The suggested High-performance liquid chromatography approach has been shown as sensitive, precise, robust, accurate, and specific and stability indicating through the resolution of Guaifenesin and Hydrocodone Bitartrate from its degradation-based compounds.

Conclusion: The established high-performance liquid chromatography technique was effectively extended to the evaluation of Guaifenesin and Hydrocodone Bitartrate in the pharmaceutical dosage form and the test results appeared satisfactory.