UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate

Abstract

The spectrophotometric methods of determination of the active pharmaceutical ingredients meloxicam and nimesulide were reviewed and a simple UV-spectrophotometric method for the determination of these active pharmaceutical ingredients in industrial equipment cleaning validation samples was proposed. The methods were based on extraction of the residual quantities of meloxicam and nimesulide from the manufacturing equipment surface by the concentrated sodium carbonate solution and the subsequent UV-spectrophotometric determination of the basic forms of the drugs at the wavelength of 362 nm for meloxicam and at 397 nm for nimesulide. The calibration graphs were linear in the range from 5 to 25 mg/L of both nimesulide and meloxicam, the molar attenuation coefficients were 6100 m2/mol for nimesulide and 9100 m2/mol for meloxicam, the limit of detection was 0.8 mg/L for nimesulide and 1.9 mg/L for meloxicam and the limit of quantification was 2.5 mg/L for nimesulide and 5.8 mg/L for meloxicam. The methods were selective with respect to the common excipients, showed a good accuracy (the relative uncertainty did not exceed 7%) and precision (the relative standard deviation did not exceed 4%), did not require lengthy sample preparation or sophisticated laboratory equipment and were suitable for the routine analysis of cleaning validation samples.