Content uniformity test of tablets by nonaqueous titration method

Area of Science:

• Pharmaceutical Analysis
• Analytical Chemistry
• Drug Quality Control

Background:

• Content uniformity testing is crucial for ensuring consistent drug dosage in tablets.
• Traditional methods may be complex or unsuitable for drugs acting as bases in non-aqueous media.

Purpose of the Study:

• To develop a simple and effective method for content uniformity testing (CUT) of tablets.
• To validate the method for active drugs that behave as bases in non-aqueous environments.

Main Methods:

• Extraction of the active drug from tablets into anhydrous acetic acid.
• Direct potentiometric titration of the extracted drug using 0.1 or 0.05 mol/l perchloric acid in anhydrous acetic acid.
• Automated recording of titration curves using a glass and calomel electrode system.

Main Results:

• The developed method demonstrated successful application to commercial tablet samples.
• The method accurately quantified drugs including codeine phosphate, embramine, ephedrine, ethylmorphine, pyridoxine, thiamine, and tolazoline hydrochlorides.
• The method is applicable to a range of other basic drugs.

Conclusions:

• A straightforward and reliable potentiometric titration method for CUT of basic drugs in tablets has been established.
• The method offers an efficient alternative for pharmaceutical quality control of various drug formulations.