Method Development and Validation of Nateglinide and Gliclazide by using RP-HPLC (Research Article)

Author(s): Gopal Rao. Paisa and Mamatha

Abstract: A new methodology was established for co-occurring estimation of Nateglinide and Gliclazide by RP-HPLC methodology. The action conditions were with success developed for the separation of Nateglinide and Gliclazide by mistreatment Xterra C18 5μm (4.6*250mm) column, rate was 1ml/min, mobile section magnitude relation was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The instrument used was WATERS HPLC automobile Sampler, Separation module 2695, organiser Detector 996, Empower-software version-2. The analytical methodology was valid consistent with ICH tips (ICH, Q2 (R1)). The dimensionality study for Nateglinide and Gliclazide was found in concentration vary of 1μg-5μg and 100μg-500μg and correlation (r2) was found to be zero.999 and 0.999, this does not imply recovery was found to be 100% and one hundred. 5%, %RSD for repeatability was 0.7 and 0.4, nothing R SD for intermediate preciseness was zero.18 and 0.39 severally.

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