STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF MITOMYCIN AND FLUOROURACIL BY USING UPLC

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable UPLC method for the measurement of active pharmaceutical ingredients of Mitomycin and Fluorouracil. Methods: A simple, selective, validated and well-defined stability that shows isocratic UPLC methodology for the quantitative determination of Mitomycin and Fluorouracil. The chromatographic strategy utilized Inertsil ODS column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 255 nm utilizing the PDA detector was given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies

BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AVELUMAB, AXITINIB AND ITS APPLICATION TO PHARMACOKINETIC STUDIES IN RABBIT PLASMA BY USING LCMS/MS

Objective: An easy, quick, precise, active and reproducible LC-MS/MS technique was developed for the bioanalytical method of Avelumab and Axitinib using Cytarabine as an internal standard. Methods: This article summarizes the recent progress on bioanalytical LC-MS/MS methods using waters x-bridge phenyl column (150x4.6 mm, 3.5µ) column and organic mobile phase of 0.1% Tri fluoro acetic acid and Acetonitrile in 50:50 ratio. Results: The calibration curve was linear in the range of 2-40 ng/ml for avelumab and 0.5-10 ng/ml axitnib. Accuracy, precision, recovery, matrix effect and stability results were found to be within the suitable limits. Simple and efficient method was developed and utilized in pharmacokinetic studies to see the investigated analyte in body fluids. Conclusion: The application denotes all the parameters of system suitability, specificity, linearity and accuracy are in good agreement with USFDA guidelines and applied effectively for the investigation of pharmacokinetic studies in rabbit

SIMULTANEOUS DETERMINATION OF FLUPENTIXOL AND NORTRIPTYLINE HCl USING RP-HPLC WITH PDA DETECTOR

Objective: In the current investigation, to separated and validate the cancer healing drugs (Nortriptyline HCl and Flupentixol) through the HPLC (e-2695) instrument containing a PDA detector. Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Nortriptyline HCl and Flupentixol. The chromatographic strategy utilized Agilent eclipse XDB column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of Methanol and 0.1% orthophosphoric acid (40:60). A flow rate of 1 ml/min and a detector wavelength of 250 nm utilizing the PDA detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. Results: LOD and LOQ concentrations for Flupentixol were 0.015 µg/ml, 0.05 µg/ml and for Nortriptyline HCl were 0.3 µg/ml, 1.0 µg/ml. The calibration charts plotted were linear with a regression coefficient of R2>0.999. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies

RAPID DETERMINATION OF CARBOPLATIN AND DOCETAXEL USİNG RP-HPLC WİTH PDA DETECTOR

Objective: In the current investigation, to separated and validate the cancer healing drugs (Carboplatin and Docetaxel) through the HPLC (e-2695) instrument containing a PDA detector. Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Carboplatin and Docetaxel. The chromatographic strategy utilized Symmetry C18 column of dimensions 150x4.6 mm, 3.5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1% ortho phosphoric acid (40:60). A flow rate of 1 ml/min and a detector wavelength of 225 nm utilizing the PDA detector were given in the instrumental settings. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999. Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies