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Development and validation of dissolution study of sustained release dextromethorphan hydrobromide tablets.
Pakistan Journal of Biological Sciences : PJBS
|June 6, 2014
Summary
This study developed and validated a reliable HPLC method for assessing Dextromethorphan hydrobromide dissolution from sustained-release tablets. The validated method ensures accurate quality control for this common cough suppressant formulation.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Sustained-release formulations require precise dissolution testing for efficacy.
- Dextromethorphan hydrobromide is a widely used antitussive agent.
Purpose of the Study:
- To develop and validate a High-Performance Liquid Chromatography (HPLC) method for dissolution testing of sustained-release Dextromethorphan hydrobromide tablets.
- To establish optimal dissolution conditions and evaluate the drug release profiles.
Main Methods:
- Utilized a C18 column with a mobile phase of 0.5% triethylamine (pH 7.5) and acetonitrile (50:50) at a detection wavelength of 280 nm.
- Validated the HPLC method for linearity (10-80 microg mL(-1)), precision (intra- and inter-run), and accuracy (Mean Recovery 101.82%).
- Optimized dissolution parameters including sink conditions, medium, and agitation intensity.
Main Results:
- The HPLC method demonstrated excellent linearity and precision, with low %RSD values for intermediate and inter-run precision.
- Mean recovery of 101.82% indicates high accuracy of the developed analytical method.
- The validated method was successfully applied to appraise the dissolution profiles of developed Dextromethorphan hydrobromide tablets.
Conclusions:
- A robust and validated HPLC method was successfully developed for the dissolution testing of sustained-release Dextromethorphan hydrobromide tablets.
- The established method provides a reliable tool for quality control and formulation development of Dextromethorphan hydrobromide products.
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