Aims: New validated method for the simultaneous estimation of Brigatinib and Alectinib using UPLC and study of its degradation. Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between March 2021 and April 2021. Methodology: Using Luna C18 100 x 2.6 mm, 1.6 µm column, acetonitrile, and 0.1 percent Tri ethyl amine (TEA) (80:20 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 260 nm. The Braginib and Alectinib peaks were resolved within 5 minutes of elution time, with the Brigatinib peak eluting at 3.208 minutes and the Alectinib peak eluting at 1.757 minutes. Results: The proposed method displays excellent linearity in the concentration ranges of 1.0 µg/ml to 15 µg/ml for Brigatinib and 5.0 µg/ml to 75 µg/ml for Alectinib. The RSD of robustness levels has a maximum of just 2 percent. Conclusion: The accuracy, specificity, and sensitivity of the method were all found to be in line with ICH guidelines, when the procedure was developed and tested.

With the quantitative analysis of Cidofovir and Famciclovir using a Symmetry C-18 150x4.6mm, 3.5 column with a flow rate of 1ml/min, a novel, quick, and accurate high performance liquid chromatographic method have been developed. The buffer is made up of 1 mL formic acid dissolved in 1 litre HPLC water, and the mobile step is made up of a 60:40 mixture of two components: Buffer and Acetonitrile. The detection was done at a wavelength of 250nm. With 8 minutes of run time, the Cidofovir and Famciclovir peaks were split, with the Cidofovir peak eluted at 2.8 minutes and the Famciclovir peak eluted at 6.4 minutes, respectively. In the concentration ranges of 7.5 g/ml to 112.5 g/ml for Cidofovir and 25 g/ml to 375 g/ml for Famciclovir, the proposed method shows strong linearity. The results of the precision and recovery studies range from 98 to 102 percent. The percent RSD in all robustness conditions is less than 2.0 percent. In stressful conditions, deterioration has a limited impact, and solutions remain stable for 24 hours. The parameters of precision, accuracy, specificity, stability, robustness, linearity, limit of detection, and limit of quantification were evaluated and found to be within the appropriate range when the method was developed and validated according to ICH guidelines.

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.

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Aims: New validated method for the estimation of Mobocertinib using HPLC and study of its degradation. Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021. Methodology: Using an X-bridge phenyl column (150 mm x 4.6 mm, 3.5 µ), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) (60:40 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 224 nm. Mobocertinib had a retention time of 2.271 minutes. The isocratic chromatography was performed at room temperature and took approximately five minutes to complete. Results: Analysis was achieved within 5 min over an honest linearity within the concentration range from 6-90 µg/ml of Mobocertinib. Using a mathematical process, the suitability parameters of the system were investigated, and the results were found to be in acceptable limits. In a linear analysis, stages with regression coefficients of 0.999 were used. LOD and LOQ values were 0.075μg/ml and 0.248 g/ml for Mobocertinib. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits. Conclusion: The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. The recommended procedure was found to be warranted according to ICH guidelines.