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UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples With Sodium Carbonate
Nikolaychuk, P.A. UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate. J 2023, 6, 248–266, doi:10.3390/j6020019.
Nikolaychuk, P.A. UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate. J 2023, 6, 248–266, doi:10.3390/j6020019.
Nikolaychuk, P.A. UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate. J 2023, 6, 248–266, doi:10.3390/j6020019.
Nikolaychuk, P.A. UV-Spectrophotometric Determination of the Active Pharmaceutical Ingredients Meloxicam and Nimesulide in Cleaning Validation Samples with Sodium Carbonate. J 2023, 6, 248–266, doi:10.3390/j6020019.
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 were proposed. The methods are based on extraction of the residual quantities of meloxicam and numesulide 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 are linear in the range from 5 to 25 mg/L of both nimesulide and meloxicam, the molar attenuation coefficients are 6100 m2/mol for nimesulide and 9100 m2/mol for meloxicam, the limit of detection is 0.8 mg/L for nimesulide and 1.9 mg/L for meloxicam, the limit of quantification is 2.5 mg/L for nimesulide and 5.8 mg/L for meloxicam, the methods are selective with respect to the common excipients, show a good accuracy (the relative uncertainty does not exceed 4%) and precision (the relative standard deviation does not exceed 5%), do not require lengthy sample preparation and sophisticated laboratory equipment and are suitable for the routine analysis of cleaning validation samples.
Chemistry and Materials Science, Analytical Chemistry
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