A Quality by Design (QBD) approach for the development and validation of RP-HPLC method for the quantification of linagliptin tablets

Abstract

This study emphasizes the pivotal role of Quality by Design (QbD) in the development of pharmaceutical methods, with a particular focus on risk assessment to ensure consistent quality. The research showcases the creation of a precise and practical HPLC method for Linagliptin Tablets, developed using QbD principles. This optimized method, designed through a systematic Design of Experiment approach, provides a robust and cost-effective solution for pharmaceutical analysis, promoting the consistent quality required within predefined specifications. The method employs C18 column (150 mm x 4.6 mm, 5μM) and employs isocratic elution with a mobile phase composed of Acetonitrile: Sodium Acetate Buffer with a pH of 4.5 in a ratio of 25:75. The flow rate was optimized at 1.0 mL/min, and peak detection was achieved using a UV detector set at 294 nm. The injection volume was standardized at 10 µL, and the Column Oven Temperature was maintained at 25°C. Rigorous validation following ICH Q 2 (R1) and USP <1225> guidelines ensure the method's reliability, with assessments of parameters such as limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, and robustness. The method's exceptional sensitivity, selectivity, efficiency, precision, accuracy, and cost-effectiveness make it an optimal choice for pharmaceutical analysis of Linagliptin Tablets.This method is intended for further use in routine analysis for quality control in the pharmaceutical industry and has demonstrated the ability to distinguish marketed products, including comparability with the innovator product.