[Quantitative determination method and application of pharmaceutical adjuvant tween 80].

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Tween 80 is a common pharmaceutical adjuvant.
• Accurate quantification of tween 80 is crucial for quality control of traditional Chinese medicine injections.

Purpose of the Study:

• To establish a rapid and accurate method for determining tween 80 content in pharmaceutical adjuvants.
• To provide reliable technical means for the quality control of traditional Chinese medicine injections.

Main Methods:

• A chromogenic reaction involving polyethoxy, ammonium thiocyanate, and tween 80 was utilized.
• Reaction kinetics, temperature, time, and organic solvent extraction were optimized.
• Spectrophotometry at 623 nm was employed for absorbance measurement.

Main Results:

• Optimized conditions involved a 2-hour reaction in a boiling water bath followed by dichloromethane extraction.
• A good linear relationship was observed between tween 80 concentration (0.8–3.0 mg) and absorbance (r=0.9996).
• The method demonstrated high accuracy (average recovery 99.66%) and precision (RSD < 2.0%).

Conclusions:

• The developed method is rapid, accurate, and suitable for determining tween 80 content in Kumu injection.
• This method is applicable to the quality control of traditional Chinese medicine injections.