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Development and Validation of a RP-HPLC Method for Estimation of Prulifloxacin in Tablet Dosage Form
S Singh1, U K Singh, R M Singh
1Dr. K. N. Modi Institute of Pharmaceutical Science, Modinagar, Ghaziabad-201 204, India.
Indian Journal of Pharmaceutical Sciences
|August 28, 2012
Summary
A new, cost-effective high-performance liquid chromatography method accurately quantifies prulifloxacin in tablets. This validated technique ensures reliable quality control for pharmaceutical analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Prulifloxacin is a fluoroquinolone antibiotic.
- Accurate quantification of active pharmaceutical ingredients is crucial for quality control.
Purpose of the Study:
- To develop and validate a simple, precise, rapid, and economic reverse-phase high-performance liquid chromatographic (RP-HPLC) method for prulifloxacin estimation in tablet dosage forms.
Main Methods:
- RP-HPLC using a C18 column.
- Mobile phase: KH2PO4 buffer: acetonitrile (10:90 v/v) at pH 7.3.
- Detection at 278 nm with a flow rate of 1.0 ml/min.
Main Results:
- Prulifloxacin retention time: 2.4 min.
- Limit of Detection (LOD): 0.14 μg/ml.
- Limit of Quantitation (LOQ): 0.42 μg/ml.
- Method validation confirmed linearity, precision, accuracy, and specificity per ICH guidelines.
Conclusions:
- The developed RP-HPLC method is suitable for routine quality control analysis of prulifloxacin in tablet formulations.
- The method offers a reliable and efficient tool for pharmaceutical analysis.
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