A new high performance liquid chromatographic (HPLC) method was developed and validated for the determination of nateglinide in pharmaceutical formulations. Optimum separation was achieved in 12 minutes using C18 column (250 mm × 4.6 mm, i.d., particle size 5 mm), and elution was accomplished using a mobile phase (1mL/min). Detection was carried out using a UV detector set at 245 nm. A linear relationship between mean peak area and concentration of nateglinide was observed in the range 1-10 µg/mL, with a detection limit of 0.05 µg/mL and a quantification limit of 0.173 µg/mL. Intra-day and Inter-day precision, and accuracy of the methods have been established according to the current ICH guidelines. The developed method was successfully applied to the determination of nateglinide in pharmaceutical formulations. The results were statistically compared with those of the reference method (UV method) by applying Student's t-test and F-test. Accuracy, evaluated by means of the recovery method, was in the range 99.83 - 99.94%, with precision (RSD) 0.89%. No interference was observed from the coformulated substances. The proposed method was successfully employed for the determination of nateglinide in various pharmaceutical preparations.
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Copy the following to cite this article:
P. R. A.; B. S. C.; A. N; S. Teja; A. B, "Quantitative analysis of nateglinide by high pressure liquid chromatographic method", Journal of Ultra Chemistry, Volume 5, Issue 2, Page Number 253-258, 2018Copy the following to cite this URL:
P. R. A.; B. S. C.; A. N; S. Teja; A. B, "Quantitative analysis of nateglinide by high pressure liquid chromatographic method", Journal of Ultra Chemistry, Volume 5, Issue 2, Page Number 253-258, 2018Available from: http://journalofchemistry.org/paper/715/