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Abstract

This study developed and validated a sensitive RP-HPLC method for the simultaneous quantification of Metformin and Sitagliptin in pharmaceutical formulations and human plasma. The method demonstrated excellent linearity, high recovery rates, and stability under various storage conditions, making it suitable for routine clinical analysis. Its simplicity and rapid analysis time of under 8 minutes enhance its applicability in resource-limited settings.

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3 views2 pages

Abstract

This study developed and validated a sensitive RP-HPLC method for the simultaneous quantification of Metformin and Sitagliptin in pharmaceutical formulations and human plasma. The method demonstrated excellent linearity, high recovery rates, and stability under various storage conditions, making it suitable for routine clinical analysis. Its simplicity and rapid analysis time of under 8 minutes enhance its applicability in resource-limited settings.

Uploaded by

balqasmm91
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Abstract

Background: The combination therapy of Metformin (MET) and Sitagliptin (SIT) is


widely prescribed for the management of Type 2 diabetes mellitus. Developing robust
analytical methods for their simultaneous quantification in biological matrices is crucial
for pharmacokinetic studies and therapeutic drug monitoring.

Objective: The primary objective of this study was to develop and validate a
sensitive, rapid, and cost-effective Reversed-Phase High-Performance Liquid
Chromatography (RP-HPLC) method for the simultaneous determination of MET and
SIT in both pharmaceutical formulations and human plasma.

Methods: Chromatographic separation was performed on a C18 column ($250 \times


4.6$ mm, $5$ $\mu$m) at ambient temperature. The optimized mobile phase consisted
of a mixture of $0.02$ M Phosphate Buffer (adjusted to pH $3.5 \pm 0.05$ with
orthophosphoric acid) and Acetonitrile in a ratio of $60:40$ (v/v), delivered
isocratically at a flow rate of $1.0$ mL/min. Detection was carried out using a UV-Vis
detector at a wavelength of $254$ nm. For bio-analytical application, plasma samples
were pretreated using a simple protein precipitation technique with cold acetonitrile as
the extracting solvent.

Results: The method demonstrated excellent linearity over a concentration range of


0.5–20 mug/mL for both drugs, with correlation coefficients ($R^ 2 $) exceeding
$0.9995. The Limit of Detection (LOD) and Limit of Quantification (LOQ) for MET
and SIT in plasma were found to be $0.05$ $\mug/mL and $0.15$ $\mug/mL,
respectively. Recovery studies showed high efficiency ($98.5\%–101.2 %$), and the
Intra-day and Inter-day precision (RSD %) were consistently below $2.0\%$. Stability
tests indicated that the analyses were stable in plasma under various storage conditions
(short-term, long-term, and freeze-thaw cycles).

Conclusion: The developed RP-HPLC method is highly specific, accurate, and stable
for the simultaneous analysis of Metformin and Sitagliptin. The simplicity of the sample
preparation and the short run time (under $8$ minutes) make this method suitable for
routine clinical analysis and bioequivalence studies in resource-limited settings.
Keywords: RP-HPLC, Metformin, Sitagliptin, Human Plasma, Method Validation,
Bioanalysis, ICH Guidelines.

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