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Development and validation of RP-HPLC method for cetrimonium bromide and lidocaine determination
A Malenovic1, M Medenica, D Ivanovic
1Department of Drug Analysis, Faculty of Pharmacy, Vojvode Stepe 450, 11000 Belgrade, Serbia and Montenegro.
Farmaco (Societa Chimica Italiana : 1989)
|March 9, 2005
Summary
A new RP-HPLC method accurately determines lidocaine and cetrimonium bromide simultaneously. This validated technique is suitable for analyzing these active pharmaceutical ingredients in commercial drug products.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Lidocaine and cetrimonium bromide are common active pharmaceutical ingredients.
- Accurate quantification is essential for quality control of pharmaceutical formulations.
Purpose of the Study:
- To develop a simple, rapid, and accurate RP-HPLC method for simultaneous determination of lidocaine and cetrimonium bromide.
- To validate the developed method for pharmaceutical analysis.
Main Methods:
- RP-HPLC using a Beckman Ultrasphere ODS column.
- Mobile phase: acetonitrile and water (72:28 V/V) at pH 2.0.
- UV detection at 208 nm with bisacodil as internal standard.
Main Results:
- The RP-HPLC method achieved simultaneous separation of lidocaine and cetrimonium bromide.
- Method validation parameters confirmed suitability and accuracy.
- The method effectively quantified drugs in the presence of pellet color corrigent.
Conclusions:
- The developed RP-HPLC method is suitable and accurate for the simultaneous determination of lidocaine and cetrimonium bromide.
- This method can be reliably used for quality control of commercial pharmaceutical formulations.