1. PITTU K CHAITANYA REDDY - Research Scholar, Bhagwant University, Ajmer, Rajasthan, INDIA.
2. Dr. PRIYANKA MATHUR - Faculty of Life Science and Applied Science, Bhagwant University, Ajmer, Rajasthan, INDIA.
Quality by Design (QbD) refers to the achievement of certain predictable quality with a predetermined and desired specification. The current studies detail QbD enable development of a simple, rapid, sensitive and cost-effective High-Performance Liquid Chromatographic method for the determination of Metformin and Linagliptin in pharmaceutical dosage forms. The factor screening studies were performed using 3-factor 21-run 2-level factorial design. System thematic optimization was performed employing split-plot design by selecting the conc of buffer, pH, and Flow rate as the critical method parameter (CMPs) identified from screening studies, thus evaluating a critical analytical attributes (CAAs) namely, retention time, peak tailing, and resolution The separation was achieved on a Thermo Scientific BDS column (250 × 4.6 mm i.d, particle size of 5 μ) using a mixture of 10 mM ammonium acetate adjusted to pH 3.3 using ortho phosphoric acid) and acetonitrile in the ratio of 35:65 %v/v as mobile phase in an isocratic elution mode, at a flow rate of 1.0 ml/min. The detection was monitored at 255 nm. The retention times of Metformin and Linagliptin were found to be 2.4 min and 4.0 min respectively. Excellent linearity range was found between 150-650 μg/ml for Metformin and 0.5-5.5 μg/ml for Linagliptin..
QBD, Metformin, Linagliptin, RP-HPLC method.