Development and Validation of UV-Spectroscopic First Order Derivative Method for Simultaneous Estimation of Rosuvastatin Calcium and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

This work aimed to develop and validate a simple, accurate, precise, and reproducible spectroscopic method for simultaneous estimation of rosuvastatin calcium and teneligliptin hydrobromide hydrate by UV-Visible first-order derivative method. According to our present knowledge, no UV method was reported for combination of rosuvastatin and teneligliptin. So, in this work, it was decided to performed the first-order derivative method and it was validated as per ICH(Q۲ R۱) guideline. Rosuvastatin calcium and teneligliptin hydrobromide hydrate showed absorbance at the working wavelength of ۲۳۰.۰۳ nm (Zero crossing point of rosuvastatin calcium) and ۲۲۲.۶۶ nm (Zero crossing point of rosuvastatin calcium), respectively, using methanol as diluent. Linearity was found over the concentration range of ۱-۴۲ µg/ml for both drugs and correlation coefficients was ۰.۹۹۹۵ and ۰.۹۹۹۴, respectively. Accuracy was found between ۹۸.۹۱%-۱۰۱.۱۳% and ۹۹.۳۸%-۱۰۰.۲۵% for rosuvastatin calcium and teneligliptin hydrobromide hydrate, respectively. LOD was found to be ۰.۲۱۳µg/ml and ۰.۱۲۰ µg/ml for rosuvastatin calcium and teneligliptin hydrobromide hydrate respectively. LOQ was found to be ۰.۶۴۶ µg/ml and ۰.۳۶۴۸ µg/ml for rosuvastatin calcium and teneligliptin hydrobromide hydrate, respectively. The result revealed that the developed method is suitable for analysis of determining rosuvastatin calcium and teneligliptin hydrobromide hydrate in a binery mixture.