Formulation of Dapagliflozin and Saxagliptin Tablets and <i>In</i> <i>vitro</i> Evaluation by RP-HPLC Method

Kommineni, Vinutha; Chowdary, K. P. R.; Prasad, S. V. U. M.

doi:10.5958/2231-5675.2019.00018.8

Cited by 8 publications

(2 citation statements)

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“…Human plasma contents of DAPA and SAX have also been simultaneously determined using HPLC, but the key drawback of this reported method is that its linearity range does not cover the maximum plasma concentration of either DAPA or SAX [15]. In addition, another HPLC method for quantitation of DAPA and SAX uses protein precipitation technique for the preparation of samples and drug extraction from human plasma [16].…”

Section: Introductionmentioning

confidence: 99%

Spectrodensitometric and ultra-performance liquid chromatographic quantification of dapagliflozin and saxagliptin in their dosage form and human plasma

Abdel-Gawad¹,

Afzal²

2022

Trop. J. Pharm Res

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Purpose: To simultaneously quantify dapagliflozin (DAPA) and saxagliptin (SAX) in a pharmaceutical product and human plasma. Methods: Separation and quantification of DAPA and SAX were performed on pre-coated TLC plates in TLC-densitometric method using a solvent system of chloroform, ethyl acetate and methanol at a volume ratio of 8:1:1 as the mobile phase. The developed spots were scanned at 225 and 210 nm in absorbance mode. Moreover, the studied drugs were concurrently determined in human plasma using ultra-performance liquid chromatography (UPLC). The separation process was carried out in WatersTM Acquity C18 BEH column using a solvent system of 0.02 M KH2PO4 buffer, pH 4; MeOH and acetonitrile (2:1:1, v:v:v) isocratically at a flow speed of 0.5 mL/min. The absorbance of each eluent was read at 220 nm. Results: Concurrent evaluation of DAPA and SAX was carried without separation using TLC-densitometric method, and it was successful in determination of DAPA and SAX in concentration ranges of 10 – 70 μg/band and 5 – 60 μg/band, respectively. In addition, retardation factor (Rf) values for SAX and DAPA were 0.17 and 0.31, respectively. Furthermore, the studied drugs were concurrently determined in human plasma using UPLC, which was sensitive enough to quantify DAPA and SAX in concentration ranges of 100 – 1000 and 20 – 200 ng/mL, respectively. Conclusion: These methods can be utilized for sensitive monitoring of DAPA and SAX in pharmacokinetic and bioequivalence studies.

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Section: Introductionmentioning

confidence: 99%

Spectrodensitometric and ultra-performance liquid chromatographic quantification of dapagliflozin and saxagliptin in their dosage form and human plasma

Abdel-Gawad¹,

Afzal²

2022

Trop. J. Pharm Res

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“…Intern, which consists of saxagliptine and dapagliflozin, is a combination medication for treating type 2 diabetes that has been approved by regulatory organizations. [5] Many HPLC [9][10][11][12][13] and a handful of LC-MS [6][7][8] techniques have been revealed for determining both medications separately and in combination. Phanindra [6] et al and Shruti [7] et al did not use deuterated substances as an internal standard in their published procedures.…”

Section: Introductionmentioning

confidence: 99%

Liquid Chromatography-Tandem Mass Spectrometry Assay Method for Estimation of Saxagliptine and Dapagliflozin in Human Plasma

Kommineni¹,

Gupta²,

Panigrahy³

et al. 2022

Journal of Pharmaceutical Negative Results

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There has been much research on both saxagliptin and dapagliflozin. However, only a few HPLC and LC-MS methods that use stable labeled isotopes to measure the amount of a drug alone or in combination with other drugs and have a longer chromatographic run time have been published. A quick and sensitive LC-MS/MS mass spectrometric test method has been made and fully validated to find dapagliflozin and saxagliptin in human plasma simultaneously. Solid-phase extraction on the Cleanert PEP-H extraction cartridge was used to separate the analyte and I.S. from the human plasma. The extracted samples were separated on an Ace Phenyl (150 X 4.6 mm, 5 m) column at a set flow rate of 0.8 mL/min using an isocratic mobile phase of acetonitrile and 5 mM ammonium acetate buffer (70:30 v/v). For dapagliflozin, the calibration curve was linear throughout a range of 0.502-227 ng/mL, while for saxagliptin, the range was 0.103-76.402 ng/mL. The procedure was validated in accordance with standards set by the U.S. Food and Drug Administration, and the outcomes are acceptable.

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Development and Validation of a Novel HPLC Method for the Simultaneous Determination of Pregabalin and Etoricoxib in Bulk and Pharmaceutical Dosage Form

Gandhimathi,

Mandava,

Kalyani

et al. 2024

Pharm Chem J

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Formulation of Dapagliflozin and Saxagliptin Tablets and In vitro Evaluation by RP-HPLC Method

Cited by 8 publications

References 0 publications

Spectrodensitometric and ultra-performance liquid chromatographic quantification of dapagliflozin and saxagliptin in their dosage form and human plasma

Spectrodensitometric and ultra-performance liquid chromatographic quantification of dapagliflozin and saxagliptin in their dosage form and human plasma

Liquid Chromatography-Tandem Mass Spectrometry Assay Method for Estimation of Saxagliptine and Dapagliflozin in Human Plasma

Development and Validation of a Novel HPLC Method for the Simultaneous Determination of Pregabalin and Etoricoxib in Bulk and Pharmaceutical Dosage Form

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