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Analysis of homatropine methylbromide dosage forms
Journal of Pharmaceutical Sciences
|January 1, 1977
Summary
A new stability-indicating analysis method for homatropine methylbromide in pharmaceuticals was developed. This spectrophotometric method accurately quantifies the drug without interference from its decomposition products.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Homatropine methylbromide is a pharmaceutical agent requiring reliable analytical methods.
- Assessing drug stability is crucial for pharmaceutical formulation development and quality control.
Purpose of the Study:
- To develop and validate a stability-indicating analytical method for homatropine methylbromide.
- To ensure the method's selectivity against known degradation products.
Main Methods:
- Formation of a picric acid-quaternary ammonium complex.
- Adsorption onto acid-washed diatomaceous earth in alkaline conditions.
- On-column chloroform extraction and spectrophotometric measurement at 365 nm.
Main Results:
- The developed method is stability-indicating for homatropine methylbromide.
- The method demonstrated selectivity, with no interference from tropinium methylbromide and mandelic acid.
Conclusions:
- A robust spectrophotometric method for analyzing homatropine methylbromide in pharmaceutical formulations has been established.
- This method provides accurate quantification and is unaffected by major hydrolytic decomposition products.