Background Using a Symmetry C18 (4.6 × 150 mm, 3.5) column, a high-performance liquid chromatographic method for quantification of Rilpivirine and Cabotegravir in active pharmaceutical ingredients was developed and validated. The mobile phase is made up of buffer, acetonitrile, and 0.1 percent formic acid in a 20:80v/v ratio. The flow rate was kept constant at 1.0 ml/min, and detection was accomplished through absorption at 231 nm with a photodiode array detector. Results The calibration curve was linear, with a regression coefficient (R2) value of 0.999 and concentrations ranging from 30 to 450 g/ml of Rilpivirine and 20–300 g/ml of Cabotegravir. The method's LOD and LOQ were 0.375 g/ml, 1.238 g/ml, and 0.25 g/ml, 0.825 g/ml for Rilpivirine and Cabotegravir, respectively. Conclusions In the forced degradation studies, the degradants were characterized by using LCMS and FTIR. The current application was found to be simple, economical, and suitable, and validated according to ICH guidelines.
Aims: The present application is a Newly Validated Reverse Phase-High Performance Liquid Chromatography Method for the Assay of Dexmethylphenidate and Serdexmethylphenidate with PDA. Study design: Mentioned study is a quick, rapid, economical, precise, and accurate reverse phase- high performance liquid chromatographic method for estimating Dexmethylphenidate and Serdexmethylphenidate. Place and duration of study: The present assay was carried out at the Shree icon Pharma laboratories PVT.ltd, Vijayawada, AP, and India, from December 2020 to February 2021. Methodology: The stationary phase Agilent C18 column with dimensions of 150x4.6mm, 3.5 was used for chromatography and pH-2.5 ammonium acetate buffer with orthophosphoric acid: acetonitrile in a 50:50 ratio used as a buffer. The detection wavelength was 265nm, and the flow rate was 1mL/min. The strategy was justified according to ICH guidelines Results: Dexmethylphenidate and Serdexmethylphenidate had retention periods of 4.258 and 5.629 minutes, respectively. For the estimation of Dexmethylphenidate and Serdexmethylphenidate, the method has been validated for linearity, accuracy, precision, stability tests, and forced degradation studies including acid, base, hydrolysis, peroxide, and thermal degradation. By multiplying the quality six times, the system's suitability parameter was investigated, and they were well within reasonable limits. The regression coefficient of the two drugs was found to be 0.999 during the linearity study, which was performed at 10% to 150 percentage points. Precision results for Dexmethylphenidate and Serdexmethylphenidate were 0.54 and 1.24, respectively. The drugs were recovered at a rate of 98-102 percent, which is within the acceptable range. Conclusion: The validation results were found to be satisfactory. It was clear that the proposed method was suitable for routine quality control and analysis of pharmaceutical preparations.
We have developed a completely unique and reliable HPLC technique for simultaneous quantification of Cisplatin and Topotecan. A chromatographic detachment was attained on a XDB C18 column (150x4.6mm, 3.5 µ) using isocratic elution with a buffer containing buffer and acetonitrile with the proportion of 60:40 as a movable phase with a flow of 1 mL/min at room temperature and UV detection was carried out at 262 nm. Dissolve 1mL of triethylamine in 1 lt of HPLC grade water and filter through 0.45 µ filter paper. This solution was used as a buffer. 10 min run time was used to separate Cisplatin and Topotecan. The analysis was achieved within 15 min over honest linearity within the concentration range from 5-75 µg/mL of Cisplatin and 2-30 µg/mL of Topotecan. By injecting the standard six times, system suitability parameters were studied and the outcomes were under the acceptable limit. Precision and recovery study results were found to be within a suitable limit. By using the above technique, the assay of the marketed formulation was performed and found to be within the limit. Degradation studies were carried out on Cisplatin and Topotecan, with a purity threshold greater than the purity angle in all conditions and within the acceptable range. The above-mentioned technique was validated according to ICH guidelines.
Background: Lenvatinib is a potent drug utilized in the medication of thyroid cancer and it acts as a tyrosine kinase inhibitor. Thus, the development and validation of Lenvatinib and allied impurities in rat plasma, and its pharmacokinetic study, are one of the most significant areas of modern pharmaceutical analysis. Objective: The current study conducts bioanalytical system validation and pharmacokinetic analysis of Lenvatinib and associated impurities in rat plasma with LC-MS/MS. Methods: The current study involves bioanalytical system validation and pharmacokinetic analysis of Lenvatinib and associated impurities in rat plasma using LC-MS/MS. Gradient elution of Lenvatinib with a flow rate of 1 mL/min and an X-Bridge phenyl column (150x4.6 mm, 3.5μ) was used in the optimized process. In this method, buffer (1 mL formic acid in 1 liter of water) and acetonitrile mixture was used as the mobile phase. Results: By using Carfilzomib as the internal norm and impurity-4 as the active metabolite and 30 minute run time, Lenvatinib and its associated impurities were separated. The linearity was in the range of 10 percent to 200 percent of rat plasma, and each analyte R2 value was found to be 0.999. Conclusion: This work indicates that all parameters, such as precision, recovery, accuracy, and stability, were achieved as per USFDA guidelines. This approach can be used to investigate Lenvatinib impurities and conduct pharmacokinetic studies involving rat plasma.
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