P. Sridevi

A rapid stability-indicating RP-HPLC was developed and validated for the estimation of Mirabegron and Solifenacin combination in bulk and tablet dosage form using Thermo C18 column (250 x 4.6 mm, 5m) as a stationary phase and a mixture solution of 0.1 percent Diazanium sulphate buffer: Acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1 ml/min. A photodiode array detector was used for detection at 246 nm. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were all determined. The peak area response-concentration curve was rectilinear over the concentration ranges of 25-75 g/ml (Mirabegron) and 2.5-7.5 g/ml (Solifenacin), with quantitation limits of 0.793 g/ml (Mirabegron) and 0.307 g/ml (Solifenacin). The proposed method was validated for the simultaneous determination of mifepristone and misoprostol in combined tablet dosage form. In comparison to previously reported RP-HPLC methods, the performance of the proposed method was found to be rapid and cost-effective. The developed and validated stability-indicating RP-HPLC method was suitable for quality control and drug analysis.

A simple, Accurate, precise method was developed for the simultaneous estimation of the Bempedoic acid and Ezetimibe in bulk and tablet dosage form.(1) Chromatogram was run through Kromosil C18 150 x 4.6 mm, 3.0m. Mobile phase containing 0.01N Kh2Po4 Buffer: Methanol taken in the ratio 70:30 was pumped through the column at a flow rate of 0.9ml/min. The buffer used in this method was 0.01N Kh2Po4 buffer. Temperature was maintained at 30°C. The optimized wavelength selected was 260.0 nm. The retention time of Bempedoic acid and Ezetimibe was found to be 2.780min and 2.123min. %RSD of the Bempedoic acid and Ezetimibe were found to be 0.6 and 1.3 respectively. % Recovery was obtained as 99.87% and 100.12% for Bempedoic acid and Ezetimibe respectively. LOQ, and LOD values obtained from regression equations of Bempedoic acid and Ezetimibe were 0.10, 0.35, and 0.01, 0.03 respectively. The regression equation of Bempedoic acid is y = 28262x + 4418.6, and y = 28796x + 190.13 of Ezetimibe. Retention times were decreased and that run time was decreased, so the method developed was simple and economical and can be adopted in regular Quality control tests in Industries.       

A simple, precise, and accurate method was developed for the simultaneous estimation of Nivolumab (NVM) and Cabozantinib (CBZ) in tablet dosage form.  The chromatogram was analyzed through a Phenomenex C18 150 mm (4.6 x 150 mm, 5 m) for chromatogram processing. A mobile phase containing formic acid: methanol (50:50) was pumped through the column at a spurge flow of 1.0 mL/min.  The column temperature was upheld at 30°C.  The quantification was done at 260.0 nm.  The elution time of NVM and CBZ was found to be 2.243 min and 2.953 min, respectively. The validation for the developed method was performed and all the parameters were found within the specified limits. The standard curve results represent a correlation coefficient of more than 0.999.  The %RSD of NVM and CBZ were found to be 0.9 and 0.7, respectively.  % Recovery was achieved as 99.88% and 99.66% for NVB and CBZ, respectively. The NVM and CBZ regression equations yielded LOD and LOQ values of 0.63, 1.91, and 0.08, 0.24 respectively. The equation of Nivolumab y is 39306x + 12173 while the Cabozantinib y is 34894x + 1139.7. With all the parameters under the criteria, the developed method for the simultaneous estimation of Nivolumab and Cabozantinib can be successfully applied for regular quality control approaches.

A Stability indicating isocratic liquid chromatographic method with UV detection at 255 nm is described for simultaneous determination of sofosbuvir and velpatasvir  in its bulk and tablet dosage form. Chromatographic separation of two drugs was achieved on a YMC column (4.6×15mm,5 ) using a mobile phase consisting of a binary mixture of acetonitrile and 0.025M KH2PO4  adjusted to pH3..0 with orthophosphoric acid in ratio 50:50. The developed Liquid Chromatographic method offers symmetric peak shape, good resolution and reasonable retention time for both drugs. Linearity, accuracy and precision were found to be acceptable over the concentration range of 50-250 µg/ml for velpatasvir and 200-1000µg/ml for sofosbuvir and R2 found to be 0.999. Accuracy was measured via recovery studies and found to be acceptable, and the percentage recoveries were found in the range of 97-103%.Method precision results obtained are 0.1%RSD for sofosbuvir and 0.8%RSD for velpatasvir. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic and thermal degradation. The proposed method was successfully validated and applied for the quantitative estimation of these drugs in both bulk and tablet dosage forms. The LC method can be used for the quality control of formulated products containing sofosbuvir and velpatasvir.