Development and validation of high performance liquid chromatography with a spectrophotometric detection method for the chemical purity and assay of nepafenac

- New HPLC UV method was developed to analyze the chemical purity and to determine the assay of nepafenac.
- 8 impurities of nepafenac (degradation and post synthesis products) were separated within 29 min.
- The degradation studies were carried on to verify the separation efficiency of the method.
- The developed method allows simultaneous determination of nepafenac amount.
- 3 nepafenac batches from manufacturing process were analyzed.