Development and Validation of HPLC Method for Determination of Nateglinide in Drug Substances

Abstract

The scope of this study was the development of a reliable, rapid, simple, sensitive, precise reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for determination of assay of the Nateglinide drug substances. The method was developed on  ACE C₁₈ analytical column (150mm x 4.6 mm i.d., particle size 5.0 µm) using a mobile phase of acetonitrile and 0.05% trifluoroacetic acid (25:25, v/v). The elute was monitored with the UV detector at 210 nm with a flow rate of 1.5 mL/min. Calibration curve was linear over the concentration range of 0,2846-1,0125 mg/mL. The retention time of Nateglinide was 7.07 min and the correlation coefficient (r) of the regression equation for the Nateglinide was greater than 0.99 in all cases.

 

KEYWORDS :Nateglinide, HPLC,  assay, method validation

Keywords

• Nateglinide, HPLC assay, method validation

ORIGINAL RESEARCH

Abstract

References

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