TLC-spectrodensitometric method for simultaneous determination of dapagliflozin and rosuvastatin in rabbit plasma: stability indicating assay and kinetic studies

Abbas, Noha S.; Derayea, Sayed M.; Omar, Mahmoud A.; Saleh, Gamal A.

doi:10.1039/d0ra05628f

Cited by 8 publications

(2 citation statements)

References 29 publications

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“…Some high-performance thin-layer chromatography (HPTLC) methods are reported for the assay of NOACs and ROS either alone or in combination with other drugs in bulk & pharmaceutical formulations [, , , , , , , 7,8,9,10,11,12,13,14]. RIV is assayed using HPTLC in human plasma [15] and also HPTLC is used to quantify ROS in rabbit plasma [16]. Most bioanalytical techniques available in the literature to quantify NOACs are based on liquid chromatography in human plasma; using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) [, 17, 18], high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) [, , 19,20,21], high-performance liquid chromatography-mass spectrometry (HPLC-MS) [22] and high-performance liquid chromatography-diode array detector (HPLC-DAD) [23].…”

Section: Introductionmentioning

confidence: 99%

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

Hamdy

Korany

Ebied

et al. 2022

JPC-J Planar Chromat

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The importance of the binary mixtures of the novel oral anticoagulants (NOACs): apixaban (APX), edoxaban tosylate (EDX) and rivaroxaban (RIV) with the lipid-lowering statin, rosuvastatin calcium (ROS) is highly emerging to save lives of cardiovascular patients as these combinations are used in prophylaxis from stroke. A high-performance thin-layer chromatography (HPTLC) method was developed for the quantitative assay of these life-saving mixtures in tablets and human plasma. Two mobile phases were developed for the assay in bulk and tablets; the first one: toluene‒ethyl acetate‒methanol‒25% ammonia (3.5:4.5:2:0.2, V/V) (method I) used for the three mixtures, and the second one: methanol‒25% ammonia (9.95:0.05, V/V) (method II) used for EDX/ROS mixture only. For analysis in human plasma, APX was used as internal standard in RIV/ROS and EDX/ROS mixtures using methods I and II, respectively, while RIV was used as internal standard in APX/ROS mixture using method I; the methods were validated according to the Food and Drug Administration (FDA) regulation for analysis in biological fluids. The method selectivity was demonstrated by its ability to simultaneously analyze the drugs in the presence of dosage form excipients and in the presence of plasma interferences (analysis in biological fluid) at single wavelength (291 nm) by use of the internal standard.

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Section: Introductionmentioning

confidence: 99%

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

Hamdy

Korany

Ebied

et al. 2022

JPC-J Planar Chromat

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“…As a result, they are used in combination therapy with other antidiabetic drugs such as MET (Lajara, 2014). The reported methods for analysis of DAPA and MET in combination include UV spectrophotometry (Bhavyasri & Surekha, 2020; Jani et al, 2015), RP‐HPLC (Abbas et al, 2020; Khalil et al, 2018; Urooj et al, 2017), LC–UV (Hassib et al, 2019), LC–MS/MS (Dias et al, 2019; Shah et al, 2019), capillary electrophoresis (Maher et al, 2019) and TLC–spectrodensitometric methods for simultaneous analysis of DAPA and MET (Abdelrahman et al, 2020; Nasser et al, 2018). These methods are less sensitive with several mobile phases and are applied only to pharmaceutical formulations.…”

Section: Introductionmentioning

confidence: 99%

Simple TLC–spectrodensitometric method for studying lipophilicity and quantitative analysis of hypoglycemic drugs in their binary mixture

Abbas

Mohamed

Derayea

et al. 2021

Biomedical Chromatography

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A selective and simple salting‐out‐assisted thin‐layer chromatographic methodology was developed for the simultaneous determination of two oral hypoglycemic drugs, dapagliflozin (DAPA) and metformin (MET) in their pure forms, tablets and spiked human plasma samples. Silica gel 60 F254 plates were used in the separation of the two drugs using a mobile phase consisting of 0.5 m (NH4)2SO4 and methanol (3:7, v/v). The plates were scanned in the reflectance mode at λmax = 237 nm. The obtained retardation factor (Rf) values for DAPA and MET were 0.77 ± 0.02 and 0.25 ± 0.02, respectively. The thin‐layer chromatography method was validated according to International Conference on Harmonization guidelines. The peak areas were linearly increased with the increases in concentrations of 45–1,000 and 50–1,500 ng/band for DAPA and MET, respectively. Moreover, the method was applied to estimate the molecular lipophilicity parameters of DAPA and MET via retention data. The suggested method was efficiently utilized for the analysis of DAPA and MET in pharmaceutical tablets and plasma samples with recoveries 98.4–100.4 and RSDs in the ranges of 1.4–2.6 and 2.2–3.0% for DAPA and MET, respectively.

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Whiteness and greenness assessments of a sensitive HPLC method with fluorimetric detection for dapagliflozin quantitation in human plasma: Application to a healthy human volunteer

Habeeb,

Morshedy,

Daabees

et al. 2024

Archiv der Pharmazie

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The evident ecological impact of human actions, like air pollution, global warming, and ozone depletion, underscores the need for environmentally friendly approaches across various domains, including analytical chemistry. This study aimed to establish a validated, eco‐friendly, and sustainable approach utilizing a fluorescence detector coupled with high‐performance liquid chromatography for quantifying the antihyperglycemic agent dapagliflozin (DAPA), in human plasma. This method employed a C18 Microsorb MV (4.5 × 250 mm, 5 μm [particle size]) column at 40°C, with 40:60% v/v isocratic elution of acetonitrile and (0.1%) orthophosphoric acid as the mobile phase at 1 mL/min flow rate. DAPA and the internal standard demonstrated their greatest response by performing excitation at 225 nm (λex) and recording chromatograms at an emission wavelength (λem) equal to 305 nm. The presented approach demonstrated high linearity between 50 and 2000 ng/mL and full adherence to the guidelines of the US Food and Drug Administration regarding the validation of bioanalytical methods. The described technique was effectively used for quantification of DAPA in human plasma samples from a healthy male participant who received a tablet of 10 mg DAPA. Analytical Eco‐Scale, Analytical GREEnness metric, and the recently created ChlorTox Scale were utilized for greenness assessment. Additionally, the “Red, Green, and Blue 12” model was used in whiteness evaluation.

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TLC-spectrodensitometric method for simultaneous determination of dapagliflozin and rosuvastatin in rabbit plasma: stability indicating assay and kinetic studies

Abstract: Mixtures of DAPA and ROSV were separated using ethyl acetate : methanol (5 : 0.1 v/v) as mobile phase and applied in plasma and urine samples in addition to stability indicating and kinetic studies.

Cited by 8 publications

References 29 publications

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

Simple TLC–spectrodensitometric method for studying lipophilicity and quantitative analysis of hypoglycemic drugs in their binary mixture

Whiteness and greenness assessments of a sensitive HPLC method with fluorimetric detection for dapagliflozin quantitation in human plasma: Application to a healthy human volunteer

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