A:Determination of Novel Promising Combination of Linagliptin and Pioglitazone HCl in Bulk and Laboratory Synthetic Mixture by Earth-Friendly Three Spectrophotometric Methods

Document Type : Original Article

Authors

1 Pharmaceutical chemistry,faculty of pharmacy,El menuofia university,Shebeen El koom,Egypt

2 Analytical Chemistry, Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt.

3 Medicinal Chemistry, Faculty of Pharmacy, suez canal University, Ismailia , Egypt.

4 Department of Medicinal Chemistry, Faculty of Pharmacy, Suez Canal University

Abstract

The combination between peroxisome proliferator-activated receptor-gamma (PPAR-γ) agonists and dipeptidyl peptidase-IV (DPP-IV) inhibitors is proven to be a more effective management of type-II diabetes mellitus (T2DM), compared to either each as single therapy. One of the novelist promising combination is linagliptin (LIN) and pioglitazone HCl (PIO) within clinical trials phase-III. Three simple, precise, accurate, reliable, and earth-friendly spectrophotometric techniques were defined and validated for resolving this novel pharmaceutical combination within laboratory synthetic mixtures and bulk form without the need of previous separation. Method-I was first-derivative (D1) spectrophotometry based on estimating LIN at 247.80 nm absorbance (PIO's zero-crossing point) and PIO at 258.40 nm absorbance (LIN's zero-crossing point) exhibiting mean percentage recoveries of 100.55% and 99.40%, respectively. Method-II was area under curve (AUC) technique involving area measurements at two designated wavelength ranges; 292-305 nm and 265-279 nm for respective LIN and PIO determination and with respective mean percentage recoveries 99.65% and 99.67%. Method-III was isosbestic point spectrophotometry where collective concentrations of both analytes were estimated at isosbestic point. 273.05 nm. Concerning PIO, the concentrations were furnished through simple deduction of LIN concentration, previously determined by AUC technique, and a mean % recovery of 99.88 % was obtained. All three proposed techniques were linear over concentration range 6-30 μg/mL and 5-50 μg/mL for LIN and PIO, respectively. Moreover, such techniques were validated as through the laboratory-prepared mixtures as refer to the International Council for Harmonization (ICH) guidelines.

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