UPLCMS Method Development and Validation of Tablet Dosage form Containing Glimepiride, Metformin and Pioglitazone Using Internal Standard

Tengli, Anandkumar

doi:10.9790/3013-04106-14

Cited by 3 publications

(3 citation statements)

References 9 publications

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“…The impact of the matrix effect on ionization and analyte quantitation was minimal since the small IS-normalized matrix factors were estimated for LIN and PIO being 1.06–1.23 and 0.93–1.08, respectively. Based on the overall presented validation data, the proposed method is better than other reported methods (refs − ,− ,− , ) for target analyte determination in terms of sensitivity (LOD 0.045 and 0.09 ng/mL), simplicity, small plasma volume (100 μL), sample processing, and run time. Table provides a summary of the method comparison between the reported and the current approaches.…”

Section: Resultsmentioning

confidence: 83%

“…23−30 These existing methodologies suffer from several limitations, where again some of these techniques require large plasma volumes (0.25−1 mL), 26,27 require long run time, 30 or are time nonefficient, tedious, and sophisticated for analytes extraction from biological matrices. [24][25][26]28 To the best of our knowledge, no bioanalytical technique has been developed regarding the simultaneous estimation of LIN and PIO within biological matrices. Thus, it is commendable to investigate such bioanalytical techniques to be applied within their bioequivalence, pharmacokinetics, and therapeutic drug monitoring investigations.…”

Section: ■ Introductionmentioning

confidence: 99%

“…Finally, several reported studies adopted the isotopic LIN, 13 C 3 LIN, ,,− or deuterated LIN (LIN-d4), , as the internal standard, which are unavailable from authorized commercial suppliers, and their custom synthesis will add to the time and cost of goads of the bioanalytical technique. On a similar basis, limited numbers of LC/MS techniques are presented for quantifying PIO as a sole analyte or simultaneously with other oral hypoglycemic agents. − These existing methodologies suffer from several limitations, where again some of these techniques require large plasma volumes (0.25–1 mL), , require long run time, or are time nonefficient, tedious, and sophisticated for analytes extraction from biological matrices. − , …”

Section: Introductionmentioning

confidence: 99%

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Unveiling Pharmacokinetics and Drug Interaction of Linagliptin and Pioglitazone HCl in Rat Plasma Using LC-MS/MS

Aref,

Hammad,

Darwish

et al. 2024

Chem. Res. Toxicol.

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The linagliptin (LIN) and pioglitazone HCl (PIO) combination, currently undergoing phase III clinical trials for diabetes mellitus treatment, demonstrated significant improvements in glycemic control. However, the absence of an analytical method for simultaneous determination in biological fluids highlights a crucial gap. This underscores the pressing need for sensitive bioanalytical methods, emphasizing the paramount importance of developing such tools to advance diabetes management strategies and enhance patient care. Herein, a sensitive reverse-phase high-performance liquid chromatography−electrospray ionizationtandem mass spectrometry method was developed for simultaneous determination of LIN and PIO in rat plasma using alogliptin as an internal standard. Chromatographic separation was performed on an Agilent Eclipse Plus C18 (4.6 × 100 mm, 3.5 μm) using an isocratic mobile phase system consisting of ammonium formate (pH 4.5) and methanol using an acetonitrile-induced protein precipitation technique for sample preparation. Multiple reaction monitoring in positive ion mode was used for quantitation of the precursor to production at m/z 473.2 → 419.9 for LIN, 357.1 → 134.2 for PIO, and 340.3 → 116.1 for ALO. The linearity range was 0.5 to 100 and 1 to 2000 ng/mL for LIN and PIO, respectively. The developed method was validated as per US-FDA guidelines and successfully applied to clinical pharmacokinetic and drug−drug interaction studies with a single oral administration of LIN and PIO in rat plasma. Pharmacokinetic parameters of LIN were significantly influenced by the concomitant administration of PIO and vice versa. Molecular modeling revealed the significant interaction of LIN and PIO with P-glycoprotein. Therefore, the drug−drug interaction between LIN and PIO deserves further study to improve drug therapy and prevent dangerous adverse effects.

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Section: Resultsmentioning

confidence: 83%

Section: ■ Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Unveiling Pharmacokinetics and Drug Interaction of Linagliptin and Pioglitazone HCl in Rat Plasma Using LC-MS/MS

Aref,

Hammad,

Darwish

et al. 2024

Chem. Res. Toxicol.

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Simultaneous determination of metformin and glimepiride in human serum by ultra high performance liquid chromatography quadrupole time of flight mass spectrometry detection

Strugaru

Kazakova

Brebu

et al. 2019

Journal of Pharmaceutical and Biomedical Analysis

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Eco-friendly HPLC method by using response surface design to measure a combination of three antidiabetic drugs

Al-Tannak,

Hemdan

2023

Reviews in Analytical Chemistry

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In recent years, there has been a significant increase in the application of green chemistry principles in analytical chemistry. One of the key factors affecting the environmental sustainability of analytical methods is the choice of solvent. In this particular study, a two-factor, three-level response surface design was employed to develop an environmentally friendly chromatographic technique for a mixture of metformin, glimepiride, and pioglitazone. Ethanol, which is known to be harmless to the environment, was chosen as the organic modifier in the mobile phase. The separation of the mixture was achieved using a phosphate buffer solution (pH 3) mixed with ethanol (30:70 v/v). The linearity of the developed method covered a concentration of metformin of 10–120 µg·mL−1 with a correlation coefficient of 0.9998, glimepiride of 0.1–20 µg·mL−1 with a correlation coefficient of 0.9997, and pioglitazone of 1–50 µg·mL−1 with a correlation coefficient of 0.9999. To evaluate the environmental friendliness of the developed method, two assessment tools were employed: The Analytical GREEnness metric and Green Analytical Procedure Index. The results revealed that the developed method performed exceptionally well in terms of its eco-friendliness. Furthermore, the developed method was compared to other reported methods in terms of both accuracy and environmental sustainability. The results demonstrated that the developed method serves as an excellent alternative to well-established techniques for the separation and quantification of the analyzed mixture. Overall, this study highlights the importance of integrating green chemistry principles into analytical chemistry practices.

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UPLCMS Method Development and Validation of Tablet Dosage form Containing Glimepiride, Metformin and Pioglitazone Using Internal Standard

Cited by 3 publications

References 9 publications

Unveiling Pharmacokinetics and Drug Interaction of Linagliptin and Pioglitazone HCl in Rat Plasma Using LC-MS/MS

Unveiling Pharmacokinetics and Drug Interaction of Linagliptin and Pioglitazone HCl in Rat Plasma Using LC-MS/MS

Simultaneous determination of metformin and glimepiride in human serum by ultra high performance liquid chromatography quadrupole time of flight mass spectrometry detection

Eco-friendly HPLC method by using response surface design to measure a combination of three antidiabetic drugs

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