High-Performance Liquid Chromatographic Assay of Nateglinide and its Stability Study

Abstract

Nateglinide (NTG) is a D-phenylalanine derivative used in the treatment of type-2 diabetes mellitus. An accurate, sensitive and reproducible high-performance liquid chromatographic (HPLC) method has been developed and validated for the quantification of NTG in pharmaceutical samples. The drug was eluted from Inertsil ODS 3V (150×4.6 mm; 5 µm particle size) column at 30^á´¼C with a mobile phase consisting of phosphate buffer of pH 3.3 and methanol (70:30 v/v). The flow rate was 1 mlmin^-1 and the UV detector was set at 210 nm to monitor the effluent. The retention behaviour of NTG as a function of mobile phase pH, composition and flowrate was investigated. Quantification was achieved by the measurement of mean peak area and the calibration curve was linear (r=0.9998) over the concentration range, 1–300 µg.ml^-1. Limits of detection (LOD) and quantification (LOQ), calculated as per ICH guidelines, were 0.1 and 0.3 µg.ml^-1, respectively. Intra-day and inter-day precisions expressed as RSD were <1% and the corresponding accuracies were better than 1.2% (RE). The method was also validated for robustness, ruggedness and selectivity. The method was applied to the determination of NTG in commercial tablets and the results agreed well with the label claim and those obtained by the reference method. Accuracy was also assessed by recovery test via standard-addition procedure. As part of degradation study, drug was subjected to forced degradation via acid- and base- hydrolysis, oxidation, thermolysis and photolysis, and the results revealed that the drug was degraded completely under oxidative stress condition and partly under base-induced stress condition. The drug remained intact when subjected to other stress conditions.

Keywords: Nateglinide, determination, HPLC, pharmaceuticals, stress-testing

Cite this Article

Basavaiah K, Rajendraprasad N, Vinay KB. High-Performance Liquid Chromatographic Assay of Nateglinide and its Stability Study. Research and Reviews: A Journal of Pharmaceutical Science. 2016; 7(3): 41–52p.