Development and Validation of a Simple, Rapid, and Sensitive Reverse-Phase High-Performance Liquid Chromatographic Method for Simultaneous Estimation of Metformin Hydrochloride and Sitagliptin Phosphate in Bulk Drug and Pharmaceutical Dosage Forms

Arjun Patel, Dr. Sneha Nair

School of Pharmacy, Birla Institute of Technology and Science Pilani, Pilani, India

ABSTRACT

A reverse-phase high-performance liquid chromatography (RP-HPLC) method that is straightforward, quick, accurate, and sensitive was devised and validated for the concurrent measurement of Metformin Hydrochloride (MET) and Sitagliptin Phosphate (SIT) in both bulk drug and pharmaceutical dosage forms. The chromatographic separation utilized a C18 column, with a mobile phase optimized to include phosphate buffer (pH adjusted using orthophosphoric acid) and acetonitrile in an isocratic mode. A UV detector was employed for detection at a wavelength optimized for both analytes. Validation of the method was conducted in line with International Council for Harmonisation (ICH) guidelines, assessing specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method demonstrated excellent linearity across concentration ranges relevant to dosage forms, with correlation coefficients exceeding 0.999 for both drugs. Recovery studies confirmed accuracy between 98–102%, and %RSD values were below 2%, indicating good precision and reproducibility. This RP-HPLC method was found to be simple, cost-effective, and appropriate for routine quality control analysis of Metformin Hydrochloride and Sitagliptin Phosphate in combined pharmaceutical formulations.

KEYWORDS

Metformin Hydrochloride; Sitagliptin Phosphate; RP-HPLC; Method Creation; Validation; Concurrent Assessment; Pharmaceutical Dosage Forms; ICH Guidelines.