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Aim: The current study dealt with the degradation behavior of Bilastine and degradation kinetics of a drug in solution state. Background:  Very limited information on the effect of pH on maximum stability has been published. In order to understand the degradation kinetics of bilastine, aqueous stability studies were carried out, because such studies on bilastine have not been reported in the literature, further no methods have reported about shelf-life determination of bilastine. The study design involves selection of stability indicating RP-HPLC method for estimation of drug then evaluation of degradation kinetics, shelf-life determination and validation of proposed method. Results: The Shimadzu HPLC series 1100 was used for stress degradation analysis of bilastine in tablet dosage form. The analysis was performed using Agilent ZORBAX SB-C8 (4.6×150×5µm) column and Phosphate Buffer: Acetonitrile (pH-5.0) in the ratio of 60:40 as mobile phase; wavelength selected for analysis was 254nm with the flow rate of 1mL/min at which drug showed sharp peak. The analysis was performed on the isocratic pump mode with the injection volume of 20µl. The mobile phase is used as diluent. The proposed method was found to be linear over the range 10 to 50 µg/mL. The analysis was performed by placing standard and samples with 7 different pH buffer, oxidative and neutral hydrolytic solutions in oven at 40ºC, 60⁰C and room temperature for an interval of 30, 60, 90, 120, 150, 180 mints for standard and samples. The results indicated that the pH, temperature, ionic strength and oxidation greatly influence the stability of Bilastine and the degradation behavior of Bilastine followed pseudo-first-order kinetics. Bilastine was most stable in neutral, alkaline, lower temperature conditions and lower ionic strength. Conclusion: The proposed method was found to be specific, selective and robust and successfully applied for its assay, degradation (stress testing) of drug and degradation kinetics in solution state. Keywords: Degradation, Stability, Bilastine, RP-HPLC, Kinetics

Objective: A simple, precise and accurate UV-spectrophotometric method is developed and statistically validated for estimation of Testosterone in gel formulation. The proposed method includes using regression equation, area under curve (AUC), first order derivative and second order derivative spectroscopic method.Methods: based on measurement of absorbance at a selected wavelength using UV-visible spectrophotometer with 1cm matched quartz cell and acetonitrile as a solvent. All developed methods obeyed Beer's-lambert's law in the concentration range of 5-25μg/mL, with correlation coefficient value less than 1. Results:The percent amount of drug estimated was nearly 100%, found to be a good agreement with label claim of marketed gel formulation. The recovery study was carried out at three different levels, the validation study data was found to be statistically significant as all the statistical parameters are within the acceptance range (% RSD <2.0 and S.D. <±2.0). Conclusions:The results of estimation and validation parameters like accuracy, precision, ruggedness, linearity and range were studied for all the developed methods and were found to be within limits. The results obtained were statistically compared using paired t-test and one way ANOVA analysis. The proposed method can be adopted for routine quality control for estimation of drug in formulation.

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The research work aims to develop a bioanalytical method using liquid chromatography and validated for the determination of canagliflozin by using an internal standard. Department of Pharmaceutical Chemistry, Smt. Kishoritai Bhoyar College of Pharmacy, New Kamptee, Nagpur (MS). Isocratic chromatography separation was achieved on an LC system with PDA detector on an ACE C18 (150mm× 4.6mm × 5µm) column using a mobile phase composition of acetonitrile: ammonium acetate buffer in the ration of 50:50 v/v (pH 4.5), orthophosphoric acid is used to adjust pH of mobile phase and the flow rate at 1.0ml/ min. and estimation was carried out at 291 nm. The retention time of a drug was 4.633 minutes. The method was validated for several parameters (specificity, linearity, precision, and accuracy) and also successfully applied for the pharmacokinetic in female rats. Calibration plot was linear (r2 > 0.9973) over the concentration range of 5-30 µg/ml for canagliflozin. The high recovery and low relative standard deviation (%RSD) confirm the suitability of the method. The result of Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found to be 0.1099 μg/ml and 0.3331 μg/ml, respectively. The new RP-HPLC method can be conveniently adapted for examining canagliflozin concentration in rat plasma after oral administration.