DEVELOPMENT OF CLEANING METHOD VALIDATION TECHNIQUES FOR PIROXICAM AND TELMISARTAN

Abstract

To determine effectiveness of cleaning, analytical methods were validated for piroxicam and telmisartan. The drugs were selected on the basis of solubility in water. Water is the major solvent used for cleaning of equipments. These drugs are practically insoluble in water, so they may leave product residue even after cleaning of the equipments and necessitate lot of water for cleaning. So, any analytical method used to determine the cleanliness should be effective. During analytical method validations, following parameters were evaluated i.e. linearity, specificity, LOQ, LOD, and recovery studies by swab sampling and rinse sampling techniques. The visual cleanliness criteria was also evaluated by spiking known amount of samples on SS plates. From the results it was concluded that the developed analytical method was sensitive and accurate. For piroxicam: UV spectrophotometric analytical method was developed which showed an absorption maxima λmax at 356 nm wavelength and linearity range 0 to 25 µg/mL. Recovery of drug from swab sampling and rinse sampling techniques were found satisfactory and within the acceptance criteria. For telmisartan, UV spectrophotometric analytical method was developed which showed an absorption maxima λmax at 226 nm wavelength and linearity range 0 to 10 µg/mL. Recovery of drug from swab sampling and rinse sampling techniques were found satisfactory and within the acceptance criteria