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A stability-indicating HPLC assay for metronidazole benzoate
Daniel K Bempong1, Ronald G Manning, Tahseen Mirza
1The United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852, USA. dkb@usp.org
Journal of Pharmaceutical and Biomedical Analysis
|June 22, 2005
Summary
A new, rapid High-Performance Liquid Chromatography (HPLC) method accurately measures metronidazole benzoate stability and purity. This validated assay is crucial for quality control of this important pharmaceutical compound.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Metronidazole benzoate is a widely used pharmaceutical agent.
- Ensuring the stability and purity of pharmaceutical compounds is critical for patient safety and drug efficacy.
Purpose of the Study:
- To develop and validate a stability-indicating High-Performance Liquid Chromatography (HPLC) assay for metronidazole benzoate.
- To assess the degradation products and solubility of metronidazole benzoate.
Main Methods:
- A stability-indicating HPLC method was developed using a Waters Symmetry C8 column.
- Detection was performed using UV at 271 nm with a mobile phase of acetonitrile and phosphate buffer.
- Validation included assessment of linearity, repeatability, and limits of detection and quantitation.
Main Results:
- The HPLC method achieved separation of metronidazole benzoate from its degradation products (metronidazole and benzoic acid) within 6 minutes.
- Excellent repeatability (injection: 0.03%, intraday: 0.4%, interday: 0.7%) and linearity (r=1.0000) were demonstrated.
- Solubility was determined in various media, and no significant hydrolysis was observed under tested conditions.
Conclusions:
- The developed HPLC assay is simple, rapid, and suitable for stability testing of metronidazole benzoate.
- The method provides accurate quantification and is robust for pharmaceutical quality control.
- Metronidazole benzoate exhibits stability under the evaluated acidic and mobile phase conditions.