A high performance liquid chromatography method for the quantitative determination assay of sitagliptin in rat plasma and its application in pharmacokinetics study

Jiu, Xiang-Fei; Shang, Dewei; Chen, Ye; Li, Xingang; Wan, Xiaomeng; Zhou, Tianhang

doi:10.5246/jcps.2011.01.009

Cited by 11 publications

(9 citation statements)

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“…High performance liquid chromatography (HPLC) coupled with various detection techniques is widely used for the qualitative and quantitative analysis in separation science. There have been analytical and bioanalytical methods reported for the determination of sitagliptin alone using HPLC 4 , LC-MS/MS 5 , HTLC-MS/MS 6 and in combination with other antidiabetic drugs using HPLC/Q-TOF MS 7 .…”

Section: Figure 1: Structure Of (R)-sitagliptinmentioning

confidence: 99%

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2014

IJPSR

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A direct chiral separation method development was carried out for sitagliptin and its (S)-enantiomer on ten diverse chiral stationary phases. Chiral stationary phases, which were tested include, R, R Whelk-O1 column, macrocyclic glycopeptides namely, Chirobiotic R (Ristocetin A), Chirobiotic V (Vancomycin), Chirobiotic T (Teicoplanin), Chirobiotic TAG (Teicoplanin aglycone), OJ-H, OJ-RH belonging to tris (4-methylbenzoate) of cellulose. Chiral selectivity was observed on polysaccharide based CSP columns namely Chiralpak IA-3, Chiralpak IC-3 belonging to tris-(3,5dimethylphenyl carbamate) of amylose, tris-(3,5-dichlorophenyl carbamate) of cellulose respectively and OD-H (tris-3,5dimethylphenylcarbamate) of cellulose. Better enantioselective separation has been achieved on cellulose tris-(3,5-dichlorophenyl carbamate) column (Chiralpak IC-3), using IPA and n-hexane as mobile phase, both containing 0.05% ethylene diamine and at 0.5 mL/min flow rate. Detection was carried out at 266nm using PDA detector and column maintained at 35ºC. The method was validated for precision, accuracy, linearity and robustness. The advantages of the method are rapid equilibration and less solvent consumption due to short column length. Efficient enantio separation (Resolution 3.38) is due to small particle size of 3 μm. Therefore this method is suitable for chiral purity determination of sitagliptin and its (S)-enantiomer. INTRODUCTION: Sitagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor class, which is in use as an oral antihyperglycemic drug 1. DPP-4 enzyme breaks down the incretins GLP-1 and GIP, the gastrointestinal hormones released in response to a meal.

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Section: Figure 1: Structure Of (R)-sitagliptinmentioning

confidence: 99%

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2014

IJPSR

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“…3), which provides a consistent response for all analytes and has a suitable dynamic range for quantification of sitagliptin and ertugliflozin [11][12][13][14]. According to literature, there are no reports of RP-HPLC-CAD technique for the simultaneous quantitation of sitagliptin and ertugliflozin as of now with high sensitivity [15][16][17][18][19][20][21][22]. Few analytical techniques were available with less sensitivity [19,20,22] for the quantification of these drugs by HPLC with ultraviolet and photodiode array.…”

Section: Introductionmentioning

confidence: 99%

A a Validated Reverse-Phase High-Performance Liquid Chromatography-Charged Aerosol Detector Technique for the Simultaneous Estimation of Sitagliptin and Ertugliflozin in Pure and Pharmaceutical Dosage Forms

Radhakrishnanand²,

Alam

et al. 2019

Asian J Pharm Clin Res

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Objective: The main objective of the present work is to develop and validate a selective reverse-phase (RP) high-performance liquid (HPLC)-charged aerosol detection technique for the quantitation of the sitagliptin and ertugliflozin in dosage form to attain high degree of sensitivity. Materials and Methods: In present HPLC technique, separation of drugs was achieved on Phenomenex C18 column (250×4.6 mm, 5 μ) with a mobile phase composition of phosphate buffer (pH – 5.8), acetonitrile, and methanol in the proportion of 40:40:20%V/V. 1 ml/min flow rate and 256 nm wavelength detection were maintained for the elution of drugs in the chromatographic system. The retaining time of sitagliptin and ertugliflozin in column was found to be 4.2 and 2.4 min, respectively. Results: The projected technique was successfully applied for the quantitation of sitagliptin and ertugliflozin as a single combined mixture. The linearity statistics for calibration curves shown a good linearity in the concentration range of 0.3125–10 μg/ml for sitagliptin and 0.0625–2.5 μg/ml for ertugliflozin. The average values of regression coefficient, slope, and intercept were 0.9998, 8688.2, and 1977.6 for sitagliptin and 0.9996, 33602, and 1852.6 for ertugliflozin. The technique was validated as per the International Council for Harmonization guidelines. The limit of detection and limit of quantification findings were 0.082 and 0.247 μg/ml for sitagliptin and 0.04 and 0.12 μg/ml for ertugliflozin. Conclusion: The developed and validated RP-HPLC-charged aerosol detector technique of sitagliptin and ertugliflozin in dosage form showed that the method was accurate and selective with high degree of sensitivity.

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“…www.ijpsr.com DOI link: http://dx.doi.org/10.13040/IJPSR.0975-8232.4 (9).3494-03 There have been several methods in the literatures for the determination of sitagliptin alone in bulk and formulation using spectrophotometer 5 , in biological fluids using HPLC 6 , LC-MS/MS 7 , HTLC-MS/MS 8 , molecularly imprinted solidphase extraction (MISPE) combined with Zwitter ionic HILIC 9 .…”

Section: Introductionmentioning

confidence: 99%

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2013

IJPSR

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The degradation pathway of sitagliptin in bulk and tablet has been investigated during stress study. Major degradation products were isolated in pure form and characterized using mass and NMR spectroscopy. Three previously unreported impurities were found to be, 3-(trifluoromethyl)-6, 7-dihydro[1,2,4]triazolo[4, 3-a]pyrazin-8(5H)-one, (2E)-1-[3-(trifluoromethyl)-5, 6-dihydro[1, 2, 4]triazolo[4, 3-a]pyrazin-7(8H)-yl]-4-(2, 4, 5-trifluorophenyl)but-2-en-1-one and (3E)-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4, 3-a]pyrazin-7(8H)-yl]-4-(2, 4, 5-trifluorophenyl)but-3-en-1-one. Further, a stability-indicating reverse phase HPLC assay method was developed on Poroshell 120 EC-C18 (3X150mm, 2.7µ) column using mobile phase consisting of 5mM ammonium acetate and acetonitrile with gradient elution in presence of spiked degradation products and impurity. The flow rate was 0.5ml/min and detection was at 210nm. The method was found to be linear over 10µg-500µg/ml (r 2 >0.999). The method was validated with respect to accuracy, precision, specificity, robustness and found to be stability indicating.

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A high performance liquid chromatography method for the quantitative determination assay of sitagliptin in rat plasma and its application in pharmacokinetics study

Cited by 11 publications

References 0 publications

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A a Validated Reverse-Phase High-Performance Liquid Chromatography-Charged Aerosol Detector Technique for the Simultaneous Estimation of Sitagliptin and Ertugliflozin in Pure and Pharmaceutical Dosage Forms

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