Article Subject
Pharmacy
Abstract

A highly sensitive isocratic reverse phase high performance liquid chromatographic method was developed and validated for the
estimation of Repaglinide and Metformin hydrochloride in Bulk drug and Pharmaceutical dosage forms. Separation of Repaglinide
and Metformin hydrochloride successfully achieved on C18, 250x4.6mm,5μ SS column or equivalent utilizing Acetonitrile: phosphate
buffer (58:42)v/v as mobile phase at a flow rate of 1mL/min and the eluates was monitored at 230 nm. Chromatogram showed peak at
a retention time of 2.053 ± 1 min and 5.537 ± 1 min. The method was validated for system suitability, linearity, precision, accuracy,
specificity, ruggedness, robustness, LOD and LOQ. Recovery of Repaglinide and Metformin hydrochloride were found to be in the
range of 99.80% and 99.70% and showing linearity in the range of 0.1-0.6 μg / ml and 25-150 μg / ml. Proposed method can be
successfully applied for the quantitative determination of Repaglinide and Metformin hydrochloride in Bulk drug and Pharmaceutical
dosage form.

Keywords
Repaglinide
Metformin hydrochloride
RP-HPLC
validation
Acetonitrile
and phosphate buffer.
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