The purpose of this study was the development and validation of an LC-MS/MS method, for the determination of solifenacin from human plasma. The sample workup involved a simple protein precipitation procedure. A core/shell type analytical column (50×2,1 mm, 2.6 Å) was used with C18 stationary phase. The mobile phase consisting of 65% acetonitril and 35% water provided good peak shape, accuracy and precision. The mass spectrometer was operated in positive electrospray ionization mode for analyte and internal standard. The following parameters were evaluated for validation purpose: Selectivity, sensitivity, matrix effect, anticoagulant effect, linearity, precision and accuracy, recovery, short and long term analyte/IS stability in solvent/matrix and carryover. The validated calibration range was 0.71-71.28 ng/ml. The correlation coefficient R 2 was at least 0.99 in all validation batches. The validated method has been successfully used for the evaluation of bioequivalence of generic solifenacin 10 mg formulations.
The purpose of this study was the development and validation of an LC-MS/MS method, for the determination of tadalafil from human plasma. The sample workup involved a simple protein precipitation procedure. A core/shell type analytical column (50×2,1 mm, 2.6 Å) was used with C18 stationary phase. The mobile phase consisting of 30% acetonitril and 70% water provided good peak shape, accuracy and precision (stable ionization). The mass spectrometer was operated in positive electrospray ionization mode for analyte and internal standard. The following parameters were evaluated for validation purpose: selectivity, sensitivity, matrix effect, anticoagulant effect, linearity, precision and accuracy, recovery, short and long term analyte/IS stability in solvent/matrix and carryover. The validated calibration range was 22.2-1111.3 ng/ml. The correlation coefficient R 2 was at least 0.9995 in all validation batches. The validated method has been successfully used for the evaluation of bioequivalence of generic tadalafil 20 mg formulations.
ABSTRACT. The purpose of this study was the development and validation of an LC-MS/MS method, for the concomitant and rapid determination amoxicillin and clavulanic acid from human plasma. The sample workup involved a simple protein precipitation procedure. A core/shell type analytical column (50×2,1 mm, 2.6 Å) was used with PFP stationary phase. A mobile phase with high aqueous composition provided satisfactory separation with good accuracy and precision (stable ionization). The mass spectrometer was operated in positive electrospray ionization mode for both analytes and internal standard. The following parameters were evaluated for validation purpose: Selectivity, sensitivity, matrix effect, anticoagulant effect, linearity, precision and accuracy, recovery, analyte/IS stability in solvent/matrix and carryover. The validated calibration range was 190-22222 ng/ml for amoxicillin, and 147-4908 ng/ml for clavulanic acid. The correlation coefficient R 2 was at least 0.99 for both analytes. The validated method has been successfully used for the evaluation bioequivalence of generic amoxicillin/potassium clavulanate formulations.
The purpose of this study was the development and validation of an LC-MS/MS method, for the determination of diclofenac from human plasma. The sample workup involved a simple protein precipitation procedure. A core/shell type analytical column (50×2,1 mm, 2.6 Å) was used with C18 stationary phase. The mobile phase consisting of 52.5% acetonitrile and 47.5% water provided good peak shape, accuracy and precision (stable ionization). The mass spectrometer was operated in negative electrospray ionization mode for analyte and internal standard. The following parameters were evaluated for validation purpose: Selectivity, sensitivity, matrix effect, anticoagulant effect, linearity, precision and accuracy, recovery, short and long term analyte/IS stability in solvent/matrix and carryover. The validated calibration range was 3.9-1194 ng/ml. The correlation coefficient R 2 was at least 0.999 in all validation batches. The validated method has been successfully used for the evaluation of bioequivalence of a generic diclofenac potassium formulation of 12.5 mg strength.
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