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RP-HPLC and UV Spectrophotometric Methods for Estimation of Pirfenidone in Pharmaceutical Formulations
V K Parmar1, S B Desai1, T Vaja1
1Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar-388120, India.
Indian Journal of Pharmaceutical Sciences
|July 19, 2014
Summary
Validated HPLC and UV spectrophotometric methods accurately quantify pirfenidone, an antifibrotic drug for idiopathic pulmonary fibrosis. These reliable techniques are suitable for pharmaceutical analysis of pirfenidone in tablet formulations.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
Background:
- Pirfenidone is a key antifibrotic agent for treating idiopathic pulmonary fibrosis (IPF).
- Accurate quantification of pirfenidone is crucial for quality control and therapeutic monitoring.
Purpose of the Study:
- To develop and validate robust analytical methods for pirfenidone determination.
- To establish reliable quantitative assays for pirfenidone in pharmaceutical formulations.
Main Methods:
- High-performance liquid chromatography (HPLC) using a reversed-phase C18 column.
- UV spectrophotometry at 317 nm.
- Method validation following International Conference on Harmonization (ICH) guidelines.
Main Results:
- HPLC and UV methods demonstrated linearity over specified ranges (0.2-5.0 μg/ml and 3-25 μg/ml, respectively).
- Both methods exhibited high accuracy (98-102% recovery) and precision (RSD <2%).
- The methods were successfully applied to determine pirfenidone content in tablet samples.
Conclusions:
- Validated HPLC and UV spectrophotometric methods provide accurate and precise quantification of pirfenidone.
- These methods are suitable for routine quality control analysis of pirfenidone in pharmaceutical products.
- The developed assays support the reliable assessment of pirfenidone in tablet formulations.
