Analytical Quality By Design (AQBD) Approach For The Simultaneous Estimation Of Antidiabetic Drugs Remogliflozin Etabonate And Teneligliptin In Bulk And Pharmaceutical Dose Forms By RP-UPLC Method

Abstract

Background: Analytical Quality by Design (AQbD) is a methodology that expands on the application of Quality by Design (QbD) principles to the life cycle management of analytical procedures, including method development, optimization, validation, and ongoing enhancement. Strong, dependable, accurate, and economical analytical techniques can be established with the aid of AQbD. Due to their complimentary mechanisms of action, Zita Plus-R combines Remogliflozin Etabonate and TGN, which are dipeptidyl peptidase-4 inhibitor (T2D) and sodium glucose co-transporter (SGLT2) management. This work seeks to design and test a reversed-phase ultra performance liquid chromatography (RP-UPLC) method based on AQbD principles for the purpose of quantifying RGN and TGN in pharmaceutical products.

Results: The chromatographic conditions were optimized by using a central composite design (CCD) with three components at five levels and Design-expert® software. To investigate the effects of temperature (X3), flow rate (X1), and the percentage of acetonitrile in the mobile phase (X2) on responses like retention time (Y1-2), resolution factor (Y3), theoretical plates (Y4-5), and tailing factor (Y6-7), a mathematical model was created. Following the software's determination of the optimal chromatographic conditions for RGN and TGN separation, the following optimal parameters were identified: 68.03%:31.97 v/v% mobile phase with acetonitrile and 0.01N phosphate buffer. UV detection at 220 nm, column temperature of 30 °C, and flow rate of 0.32 ml/min. Retention times for RGN and TGN were 1.320 minutes and 0.992 minutes, respectively. The performance of the approach was linear for RGN and TGN, with concentration ranges of 10–60 µg/ml and 2–12 µg/ml, respectively. The corresponding limits of quantification (LOQ) and limits of detection (LOD) for RGN and TGN were 0.02 µg/ml and 0.05 µg/ml and 0.11 µg/ml and 0.32 µg/ml, respectively. The relative standard deviation (%RSD) of the intraday precision percentage the interday precision % for Remogliflozin was 0.8 and for Teneligliptin below 2, and for RGN and TGN was 0.7 and 0.5 for teneligliptin, respectively. The recovery percentages for RGN and TGN were determined to be 100.20 and 99.21%, respectively. In forced degradation investigations, it was discovered that both medications were prone to oxidative and photolytic deterioration.

Conclusions: A fast, accurate, specific, and stability-indicating RP-UPLC method has been developed for the quantitative detection of RGN and TGN in pharmaceutical dosage forms using the AQbD-based methodology.