Optimization of HPLC method using central composite design for estimation of Torsemide and Eplerenone in tablet dosage form

Hinge, Madhuri Ajay; Patel, Dipti

doi:10.1590/s2175-97902022e20219

Cited by 4 publications

(3 citation statements)

References 29 publications

(29 reference statements)

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“…Thirteen experiments were designed in the CCD analysis, which was performed at various levels (−1, 0, + 1) of significant factors (Table 2). 24 HPLC Method Validation. After completing the method development and optimization processes, the validation was carried out as per ICH Q2 (R1) guidelines for the analysis of 5-FU blood plasma by estimating validation parameters.…”

Section: ■ Introductionmentioning

confidence: 99%

HSPiP, Computational Modeling, and QbD-Assisted Optimized Method Validation of 5-Fluorouracil for Transdermal Products

Hussain,

Ramzan,

Altamimi

et al. 2023

ACS Omega

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This study addressed the simplest and most efficient HPLC (high-performance liquid chromatography) method for the estimation of 5fluorouracil (5-FU) from rat blood plasma by implementing the Hansen solubility parameters (HSP), computation prediction program, and QbD (quality by design) tool. The mobile phase selection was based on the HSP predictions and experimental data. The Taguchi model identified seven variables (preoptimization) to screen two factors (mobile phase ratio as A and column temperature as B) at three levels as input parameters in "CCD (central composite design)" optimization (retention time as Y 1 and peak area as Y 2 ). The stability study (freeze−thaw cycle and short-and long-term stability) was conducted in the rat plasma. Results showed that HSPiP-based HSP values and computational model-based predictions were well simulated with the experimental solubility data. Acetonitrile (ACN) was relatively suitable over methanol as evidenced by the experimental solubility value, HSP predicted parameters (δ h of 5-FU − δ h of ACN = 8.3−8.3 = 0 as high interactive solvent whereas δ h of 5-FU − δ h of methanol = 8.3−21.7 = −13.4), and instrumental conditions. CCD-based dependent variables (Y 1 and Y 2 ) exhibited the best fit of the model as evidenced by a high value of combined desirability (0.978). The most robust method was adopted at A = 96:4 and B = 40 °C to get earlier Y 1 and high Y 2 as evidenced by high desirability (D) = 0.978 (quadratic model with p < 0.0023). The estimated values of LLOD and LLOQ were found to be 0.11 and 0.36 μg/mL, respectively with an accuracy range of 94.4−98.7%. Thus, the adopted method was the most robust, reliable, and reproducible methodology for pharmacokinetic parameters after the transdermal application of formulations in the rat.

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Section: ■ Introductionmentioning

confidence: 99%

HSPiP, Computational Modeling, and QbD-Assisted Optimized Method Validation of 5-Fluorouracil for Transdermal Products

Hussain,

Ramzan,

Altamimi

et al. 2023

ACS Omega

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“…Rivaroxaban has the following chemical formula: C19H18ClN3O5S. Its molecular weight is 435.89 g/mol, and its IUPAC nomenclature is 5-chloro-N-[(5S) [4-(3oxomorpholin -4-yl) phenyl]-2-oxo-3-Thiophene-2carboxamide, or [-1, 3-oxazolidin-5-yl]methylthiophene [1][2][3]. It belongs to a class of an anticoagulant [4].…”

Section: Introductionmentioning

confidence: 99%

Quantitative Estimation of Rivaroxaban in Bulk and Pharmaceutical Formulation using High-Pressure Liquid Chromatography in Reverse Phase

Bhavyasri¹,

Begum²,

Aishwarya³

et al. 2022

Int J Pharm Phytopharmacol Res

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Rivaroxaban is prescribed to patients with nonvalvular atrial fibrillation to reduce the risk of stroke and blood clots in blood vessels. It is applied to the management of vascular blood clots. Goal: To create a method for estimating the dosage of Rivaroxaban in tablets and bulk using RP-HPLC that is straightforward, specific, accurate, and exact. The C18 column was used to provide the optimal circumstances. Acetonitrile: water (60:40) with pH adjusted to 4 with formic acid. Flow rate maintained at 1.0 ml/min. λmax was detected at 249.5nm. The retention time for Rivaroxaban was found at 2.44min. Linearity was obtained in the range of 10-45μg/ml. Recovery studies were performed and %Recovery was found to be 99.91±0.1.%RSD was found to be within the limits i.e., less than 2. The correlation coefficient from the linearity plot was found to be 0.999. By considering all the results obtained, the method can be successfully applied for estimating Rivaroxaban in bulk and tablet dosage by RP-HPLC without interfering with any of the excipients and commonly used substances.

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“…TRS is a sulfonylurea derivative and chemically known as 3-[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl-1-propan-2-yl urea (Supporting Information Figure S1) [9]. The reported analytical approaches for assay of TRS in biological fluids and dosage forms include spectrophotometry [10,11], liquid chromatography-mass spectrometry (LC-MS) [12], high-performance thin-layer chromatography (HPTLC) [13], reversed-phase high-performance liquid chromatography (RP-HPLC) [14,15] and spectrofluorimetry [16].…”

mentioning

confidence: 99%

Highly fluorescent nitrogen‐doped carbon quantum dots prepared using sucrose and urea: Green synthesis, characterization, and use for determination of torsemide in its tablets and plasma samples

Abo Zaid,

El‐Enany,

Mostafa

et al. 2024

Luminescence

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A simple and facile microwave‐assisted method was developed for the synthesis of highly fluorescent nitrogen‐doped carbon quantum dots (N‐CQDs) using sucrose and urea. The produced quantum dots exhibited a strong emission band at 376 nm after excitation at 216 nm with quantum yield of 0.57. The as‐prepared N‐CQDs were characterized using Fourier‐transform infrared (FTIR) spectroscopy, transmission electron microscopy (TEM) images, and ultraviolet‐visible (UV‐visible) spectra. The average particle size was 7.7 nm. It was found that torsemide (TRS) caused an obvious quenching of the fluorescent N‐CQDs; so, they were used for its spectrofluorometric estimation. An excellent linear correlation was found between the fluorescence quenching of N‐CQDs and the concentration of the drug in the range of 0.10 to 1.0 μg/mL with limit of quantitation (LOQ) of 0.08 μg/mL and limit of detection (LOD) of 0.027 μg/mL. The method was successfully applied for the assay of the drug in its commercial tablets and spiked human plasma samples, and the results obtained were satisfactory. Complex GAPI was used for greenness assessment of the analytical procedures and the pre‐analysis steps. Interference likely to be introduced from co‐administered drugs was also studied.

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Optimization of HPLC method using central composite design for estimation of Torsemide and Eplerenone in tablet dosage form

Cited by 4 publications

References 29 publications

HSPiP, Computational Modeling, and QbD-Assisted Optimized Method Validation of 5-Fluorouracil for Transdermal Products

HSPiP, Computational Modeling, and QbD-Assisted Optimized Method Validation of 5-Fluorouracil for Transdermal Products

Quantitative Estimation of Rivaroxaban in Bulk and Pharmaceutical Formulation using High-Pressure Liquid Chromatography in Reverse Phase

Highly fluorescent nitrogen‐doped carbon quantum dots prepared using sucrose and urea: Green synthesis, characterization, and use for determination of torsemide in its tablets and plasma samples

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