A validated LC-MS/MS bioanalytical method for the simultaneous determination of dapagliflozin or saxagliptin with metformin in human plasma

El‐Zaher, Asmaa A.; Hashem, Hanaa Abdelmenem; Elkady, Ehab F.; Allam, M. A.

doi:10.1016/j.microc.2019.104017

Cited by 19 publications

(10 citation statements)

References 13 publications

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“…Liquid-liquid extraction method [9,10] was used to isolate DEU and TMP as IS from human plasma. 0.100 mL sample (K2 EDTA plasma) was aliquoted into Ria (polypropylene) vials.…”

Section: Sample Processingmentioning

confidence: 99%

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A Novel Bioanalytical HPLC-MS/MS Method for Deucravacitinib Determination in Human Plasma

Mahesh¹,

Haque²,

Salman³

et al. 2023

Preprint

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Plaque psoriasis is a common, long-lasting illness that affects the immune system and causes significant negative impacts on a patient's physical health, well-being, and ability to work effectively. Deucravacitinib (DEU) is the first oral medication used in the treatment of plaque psoriasis, a chronic skin condition that causes red, scaly patches on the skin. DEU is a type of medication called an oral Janus kinase (JAK) inhibitor, which works by blocking specific enzymes that play a role in the inflammation and immune response associated with psoriasis. Therefore, a quick, easy, novel, reliable, sensitive, and straightforward Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) approach was used to analyse DEU in plasma samples. The LC-MS/MS method for the determination of DEU in human plasma was based on using trimethoprim as an internal standard (IS). The separation of DEU and IS was carried out via liquid-liquid extraction (LLE). The isolated substances were then subjected to the chromatographic system using the ACE-C18 column (4.6x100 mm, 5 µm). The mobile phase employed consisted of methanol and a solution of 2 mM ammonium formate (80:20 v/v, respectively). The flow rate used was set at 0.9 mL min-1. The creative strategy was performed by running an ABSCIEX API 4000 mass spectrometer with an electron spray ionization source in Multiple Reaction Monitoring (MRM) modes. The ion transitions m/z 426.3  358.2 was used for DEU quantitation, while the ion transitions m/z 291.1  261.1 was used for trimethoprim quantitation. The accuracy, precision, linearity, recovery, and selectivity of DEU were deemed acceptable when validated for a concentration range between 0.500 to 601.050 ng/mL, utilizing a weighting factor of 1/x2.

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“…Liquid-liquid extraction method [9,10] was used to isolate DEU and TMP as IS from human plasma. 0.100 mL sample (K2 EDTA plasma) was aliquoted into Ria (polypropylene) vials.…”

Section: Sample Processingmentioning

confidence: 99%

“…Figure 2 shows how the mass characteristics for the compounds with good performance were optimized in positive ionization mode. Data from the MRM mode were evaluated to improve selectivity [9,10,13]. The m/z values of the protonated form analyte and IS, [M+H] + were 426.8 and 291.1 (Q1 mass), respectively.…”

Section: Mass Spectrophotometrymentioning

confidence: 99%

A Novel Bioanalytical HPLC-MS/MS Method for Deucravacitinib Determination in Human Plasma

Mahesh¹,

Haque²,

Salman³

et al. 2023

Preprint

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“…The anti-diabetic drug Mitiglinde targets the postprandial hyperglycemia, the studies showed the analysis of mitiglinde which involved human plasma as matrix is done through the sample preparation with LLE. While the other novel anti-diabetic drug Linagliptin is prepared through SPE involving human plasma and human urine as a matrix [7]. Table 1 is showing the sample preparation for the analysis of anti-diabetic drug through different bio-analytical procedure.…”

Section: Sample Preparationmentioning

confidence: 99%

insight of development and validation of bio-analytical method in the reference of anti-diabetic drugs by using LC-MS/MS

Swain¹,

Kar²,

Kumari³

et al. 2022

ijhs

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Diabetes mellitus, which has high rates of disability and mortality, is one of the main causes of public health concerns worldwide. It currently poses serious medical and societal issues. Different bio-analytical techniques have been developed to identify the pharmaceutical formulation of the anti-diabetic drug. Due to the continual requirement to achieve improved sensitivity, accuracy, and speed of analysis in complex biological samples, the development of bio-analytical sample preparation techniques has grown more difficult over time (e.g., blood, serum, plasma, saliva, feces, and urine). This is a mini review, and its goal is to analyze how LC-MS/MS has been used to for the pharmaceutical formulation of the anti-diabetic drugs. The method was validated for linearity, accuracy, precision, specificity, selectivity, and stability.

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“…[1][2][3] The market is ooded with many drugs for the management of diabetes and it is also prime requirement to have quality medicines a patient have to get relief from increase glucose level. Several methods available to estimate Vildagliptin (VIL) and Dapagli ogin (DAP) by using UV Spectroscopy [1][2][3][4][5], UPLC [6], RP-HPLC [7][8][9][10][11][12][13], UPLC and LC-MS/MS [14][15][16] in individual dosage form and combination with Metformin and Saxagliptin. But, no single method was available for simultaneous determination and stability indicating assay method of VIL and DAP by RP HPLC.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation and Stability Indicating Method of Vildagliptin and Dapagliflozin by Rp-hplc in Pharmaceutical Dosage Form

Patel,

Teraiya

2024

Preprint

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Vildagliptin and Dapagliflozin drugs are used for the management of diabetes.The primary objective of the proposed research was to develop and validate analytical methods for simultaneous quantification of vildagliptin and dapagliflozin in pharmaceutical dosage form. Both the drugs were subjected to force degradation to ensure stability of pharmaceutical products.The HPLC method development was carried out on C18 column (250mm*4.6mm,5µm particle size). The chromatographic separation was achieved by isocratic mode with a mixture of Methanol: 0.01% Trifluoro acetic acid (pH-2.78) in the ratio of 95:05 % v/v as mobile phase. Flow rate was kept at 0.8 ml/min and selected wavelength for estimation was 210 nm. Stress testing with acid, alkaline, oxidative and thermal degradation was performed. The retention time was found to be 2.282 min and 4.070 min for vildagliptin and dapagliflozin, respectively. The drugs response found to be linear with correlation coefficient value was nearly 0.999 for vildagliptin and dapagliflozin with linearity range of 10 – 60 µg/ml. The recoveries from studies were found to be 99.78% and 100.17% for vildagliptin and dapagliflozin respectively. LOD and LOQ were found to be lower, hence the method proved sensitivity. Method was validated as per ICH guideline Q2(R1). Drugs had shown more degradation in oxidative condition, 10.62% and 13.52% for vildagliptin and dapagliflozin, respectively. The proposed method would be successfully applied for the stability indicating, impurity separation, qualitative and quantitative estimation of vildagliptin and dapagliflozin in pharmaceutical dosage form and in process quality control analysis.

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A validated LC-MS/MS bioanalytical method for the simultaneous determination of dapagliflozin or saxagliptin with metformin in human plasma

Cited by 19 publications

References 13 publications

A Novel Bioanalytical HPLC-MS/MS Method for Deucravacitinib Determination in Human Plasma

A Novel Bioanalytical HPLC-MS/MS Method for Deucravacitinib Determination in Human Plasma

insight of development and validation of bio-analytical method in the reference of anti-diabetic drugs by using LC-MS/MS

Simultaneous Estimation and Stability Indicating Method of Vildagliptin and Dapagliflozin by Rp-hplc in Pharmaceutical Dosage Form

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