Validation of the analytical method for Repaglinide residual amount determination on the surfaces of cleanrooms and pharmaceutical equipment by means of UV spectrophotometry

Abstract

During the drugs production, one of the most important requirements of good manufacturing practice (GMP) is the equipment cleaning from active pharmaceutical substance residues, which has to be carried out to prevent cross-contamination in case of switching from the production of one drug to another. The use of a sufficiently sensitive, rapid and simple UV spectrophotomery technique for determining trace amounts of repaglinide, carried out to control the quality of cleaning and cleaning validation in pharmaceutical production, is described. This technique is validated for specificity, linearity, detection limit and quantification limit. The calibration plot is linear in the concentration range of 0.1420 0.2130 mg/ml. The detection limit is 9.87·10, the limit of quantification is 2.96·10. Keywords—validation, UV spectrophotometry, validation of analytical methods, pharmaceutical equipment cleaning, residual amount determination, repaglinide