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Background: Vismodegib (VMD) is a drug of choice for the treatment of basal-cell carcinoma. Present studies carried out to estimate VMD by RP-UPLC technique and to develop a simple, précised, accurate method for routine analysis. Methods: For this purpose Chromatographic conditions used were stationary phase STD BEH C18  column (100 mm x 2.1 mm, 1.8m), a mixture of Methanol:KH2PO4 taken in the ratio 50:50%v/v as a mobile phase with a pH 7.4 and flow rate was maintained at 0.3ml/min, detection wave length was Acquity TUV 254nm, column temperature was set to 30oC and diluent was mobile phase, Conditions were finalized as optimized method. Results: System suitability parameters were studied by injecting the standard six times. Linearity study was carried out between 25% to150% (37.5-225µg/ml) levels, R2 value was found to be as 0.9992. Precision was found to be 0.6 for repeatability and 0.4 for intermediate precision. LOD and LOQ are 0.33 µg/ml and 0.99 µg/ml respectively and results were well under the acceptance criteria. Conclusion: By using above method assay of marketed formulation was carried out and was found 100.12%. Degradation studies of VMD were done, in all conditions purity threshold was more than purity angle and within the acceptable range. The developed method was simple and can be used for routine analysis.

A selective, robust, economic and short method was developed for the simultaneous estimation of the Ertugliflozin (EGZ) and Sitagliptin (SGP) in Tablet dosage form. Chromatogram was run through X-bridge c18 50 x 2.1 mm, 1.7. Mobile phase containing Buffer: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.01N KH2PO4(3.0PH)buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 240 nm Retention time of EGZ and SGP were found to be 0.883 min and 1.465 min.%RSD of the EGZ and SGP were and found to be 0.3 and 0.8 respectively. %Recovery was obtained as 99.83% and 100.09% for EGZ and SGP respectively. LOD, LOQ values obtained from regression equations of EGZ and SGP were 0.139, 0.421 and 0.18, 0.56 respectively. Regression equation of EGZ is y = 4300x + 253.6, and y = 6814x + 11844 of SGP. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries

Acalabrutinib (ABN) is a Bruton tyrosine kinase inhibitor used to treat mantle cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma. It has been used in the treatment of Hodgkin lymphoma, multiple myeloma and ovarian cancer. It is available in capsule dosage form, usually prescribed twice a day. The objective of the present study describes the ultra-performance liquid chromatography (UPLC) method development and validation for the estimation of the ABN in Capsule dosage form by following ICH guidelines because no methods were reported in this category. The column and Mobile phase were selected based on trial and error methods. For the estimation, the chromatogram BEH C18 (50 mm x 2.1 mm, 1.7µm) column was run through with Mobile phase 0.01N KH2PO4 : Methanol in the ratio of 50:50 at a flow rate of 0.3 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected for the separation was 234nm. Retention time was achieved 1.148minute in optimized chromatogram. Theoretical plate count and tailing factor were obtained “as per recommendations of ICH limits”. The % RSD precision obtained was 0.7% and Intermediate precision obtained was 0.7% as the limit of Precision was less than 2. %Recovery obtained for marketed formulation was 99.23%. LOD, LOQ values obtained from the regression equation (y=9128.5x + 14854) of ABN were 0.18µg/ml and 0.55µg/ml respectively. Proposed method was linear over the concentration range25-150µg/ml. Different degradation studies (acid, alkali, oxidation, thermal, UV, water) were performed and all these samples passed the limits of degradation. Retention time and run time was decreased, so the method developed was simple and economical that can be adopted in regular quality control tests in Industries.