• Ms. Pradnya D. Sable
• Mrs. Swati B. Suradkar
• Mr. Mayur B. Pachunde
• Ms. Shital R. Bawaskar

An isocratic reversed- phase high- performance liquid chromatography( RP- HPLC) system has been developed for rapid-fire and contemporaneous separation and estimation of 3 antidiabetic medicines, videlicet, metformin, pioglitazone, and glimepiride, in mortal tube within 3 min. A reversed- phase RP- HPLC system was developed for the contemporaneous determination of metformin hydrochloride( MET), pioglitazone( PIO), and glimepiride( GLM) in their combined lozenge forms and spiked mortal tube. Quality threat operation principles for determining the critical system parameters (CMPs) and fractional factorial design were made to screen CMPs and latterly, the Box – Behnken design was employed. Literature check reveals good number of logical styles for the estimation of TEN and MET collectively or in combination with other medicines using UV spectrophotometry6- 8, HPLC9- 19, HPTLC20 and LC- MS/ MS21. The proposed procedure was optimized by espousing a quality- by- design approach. The influence of different factors on chromatographic responses was optimized by applying the two- position full factorial design (25). The optimum chromatographic separation was achieved using Hypersil BDS C18 column at 45 °C, and the mobile phase pumped isocratically composed of methanol potassium dihydrogen phosphate buffer(6.6 mM; pH 7, 6733 v/ v) at an inflow rate of0.814 mL/ min using 235 nm as a discovery wavelength.

RP-HPLC, metformin, pioglitazone, glimepiride, Quality by design, HPLC.

"A Review on: QbD Engineered Method Development and Validation of RP-HPLC for Simultaneous Estimation of Anti-Diabetic Agents.", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 9, page no.f454-f457, September-2023, Available :http://www.jetir.org/papers/JETIR2309553.pdf

"A Review on: QbD Engineered Method Development and Validation of RP-HPLC for Simultaneous Estimation of Anti-Diabetic Agents.", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 9, page no. ppf454-f457, September-2023, Available at : http://www.jetir.org/papers/JETIR2309553.pdf