rp-uplc method development and validation for the determination of nateglinide in bulk drug and pharmaceutical formulations: a quality by design approach

摘要

a systematic process to build quality into a productudfrom 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 anudunderstanding 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 approudach to method development and validation is prudesented on nateglinide (NTG), an antiuddiabetic drug. To facilitate studies investigating the determination of NTG in bulk drug and its pharmaceutical formulations, we developed and validated a rapidudultra performance liquid chromatography (UPLC)udmethod for determination of NTG. The validatedudlimit of quantitation (LOQ) of 0.06 μgmL-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 showedudno degradation at different stress conditions.udThe relative standard deviation (RSD) percentage forudrobustness and ruggedness were observed within the range of 0.1 and 1.74. The calibration was linear in the rangeudof 0. 06–250μg mL-1.The proposed method was compared with audpharmacopoeial reference method and found to give equivalent result. The proposed method can be used for routine analysis in quality control laboratoriesudfor its bulk and formulated product and this is the first reported UPLC method for the assay determination of NTG.