Optimized Simultaneous Estimation of Metformin, Teneligliptin, and Pioglitazone in Tablet and Bulk Drug: A...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chromatography

Background:

• Type 2 diabetes is a growing global health concern.
• Fixed-dose combinations offer improved patient compliance.
• Metformin, teneligliptin, and pioglitazone represent a new combination therapy.

Purpose of the Study:

• To develop and validate an accurate, rapid, and cost-effective analytical method.
• To quantify metformin (MET), teneligliptin (TEN), and pioglitazone (PIO) in bulk and tablet formulations.
• To establish a method with a significantly short runtime for routine analysis.

Main Methods:

• Reversed-phase ultra-fast liquid chromatography (RP-UFLC) was employed.
• Box-Behnken design was used for optimizing chromatographic conditions.
• A C18 column with a mobile phase of phosphate buffer and acetonitrile was utilized.
• Detection was performed at 255 nm.

Main Results:

• The method achieved a short runtime of 3.0 minutes.
• Quantification limits were established for MET, TEN, and PIO.
• Excellent linearity was observed across the studied concentration ranges (r² > 0.999).
• Method and intermediate precision showed relative standard deviation values <2%.

Conclusions:

• A novel, validated RP-UFLC method was successfully developed for MET, TEN, and PIO.
• The method is efficient, precise, rapid, economical, and highly accurate.
• This analytical approach is suitable for the quality control of the new fixed-dose combination drug.