Simultaneous estimation of two anti-diabetic drugs; Linagliptin and empagliflozin in their tablet by chemometric spectrophotometry.

Four spectrophotometric approaches had been established and optimized for the simultaneous estimation of two anti-diabetic drugs; linagliptin (LIN) and empagliflozin (EMP) in their bulk and tablet dosage form. LIN concentration could be first determined from the zero order spectra at its λ (293 nm) without interference from EMP as at this wavelength EMP showed zero absorbance. The LIN and EMP zero order absorption spectra displayed considerable overlap which hindered the direct determination of EMP.

Deduction of the operable design space of RP-HPLC technique for the simultaneous estimation of metformin, pioglitazone, and glimepiride.

A reversed-phase RP-HPLC method was developed for the simultaneous determination of metformin hydrochloride (MET), pioglitazone (PIO), and glimepiride (GLM) in their combined dosage forms and spiked human plasma. Quality risk management principles for determining the critical method parameters (CMPs) and fractional factorial design were made to screen CMPs and subsequently, the Box-Behnken design was employed. The analytical Quality by Design (AQbD) paradigm was used to establish the method operable design region (MODR) for the developed method depended on understanding the quality target product profile (QTPP), analytical target profile (ATP), and risk assessment for different factors that affect the method performance to develop an accurate, precise, cost-effective, and environmentally benign method.