RP-UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF NATEGLINIDE IN BULK DRUG AND PHARMACEUTICAL FORMULATIONS: A QUALITY BY DESIGN APPROACH

Quality by design (QbD) is a systematic process to build quality into a product from the inception to final output. QbD requires a thorough understanding of a product and its process of manufacture, necessitating an investment in time and resources upfront in the discovery and development of a product. For QbD, the product and process knowledge base must include an understanding of variability in raw materials, the relationship between a process and product s critical quality attributes (CQAs), and the association between CQAs and a product s clinical properties. Here, a QbD approach to method development and validation is presented on nateglinide (NTG), an antidiabetic drug. To facilitate studies investigating the determination of NTG in bulk drug and its pharmaceutical formulations, we developed and validated a rapid ultra performance liquid chromatography (UPLC) method for determination of NTG. The validated limit of quantitation (LOQ) of 0.06 μg mL-1 and limit of detection (LOD) of 0.02 μg mL-1 are low enough to allow determination of low concentrations of the drug. NTG showed no degradation at different stress conditions. The relative standard deviation (RSD) percentage for robustness and ruggedness were observed within the range of 0.1 and 1.74. The calibration was linear in the range of 0.06–250 μg mL-1. The proposed method was compared with a pharmacopoeial reference method and found to give equivalent result. The proposed method can be used for routine analysis in quality control laboratories for its bulk and formulated product and this is the first reported UPLC method for the assay determination of NTG.