| Summary: | Metformin is a polar compound if analyzed by reversed-phase of HPLC
will appear in a fast retention time, this complicates the determination of
metformin in plasma due to be overlapping between metformin peak compound
with endogenous peak compounds in plasma. To solve it, ion pairing reagent
sodium dodesil sulfate (SDS) is used. The purpose of this study is to develop and
validate the analytical methods metformin assay in spiked human plasma and
tablet dosage form by HPLC using a reversed-phase column Supelco Ascentis®
Phenyl (length 250 mm, internal diameter 4.6 mm, particle size 5μm).
HPLC system consisted of a reversed-phase column Ascentis® Phenyl
(length 250 mm, internal diameter 4.6 mm, particle size 5μm) as a stationary
phase, mixed mobile phase of acetonitrile and buffer phosphate KH2PO4 20 mM
and SDS 1 mM pH 4.0 ± 0,1 adjusted with dilute ortho phosphoric acid 10 % (30 :
70 v/v), the flow rate 1.0 mL/minute, detected by UV detector 234 nm. The
method was validated with the parameters selectivity, LOD, LOQ, linearity,
precision, accuracy and robustness.
The validation result shows that this method has selectivity, accuracy,
repeatability and intermediate precision also good robustness for the
determination of metformin HCl in spiked plasma and tablet dosage form. Range
of linearity is on 0.1 - 7 mg/mL. LOD 29.0 ng/mL and LOQ 90.7 ng/mL.
Conclusion, the analytical method that was developed can be used to
determination metformin HCl in spiked human plasma and in tablet dosage form
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