Rp-HPLC Method Development and Validation for Simultaneous Estimation of Linagliptin and Empagliflozin

Rao, A Lakshmana; Prasanthi, T.; Anusha, E. L

doi:10.53879/id.56.05.11150

Cited by 6 publications

(1 citation statement)

References 11 publications

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“…15 Empaglif lozin can be estimated using limited highperformance liquid chromatography (HPLC), reverse-phase high-performance liquid chromatography (RP-HPLC), and ultraviolet (UV) methods, according to a survey of the relevant published research. [16][17][18][19][20][21][22][23][24][25][26][27][28] This study was undertaken to determine the best RP-HPLC technique aimed at determining the quantity of empagliflozin in both bulks and pharmaceutical dosage forms. The recommendations laid out by ICH were used to perform the technique validation.…”

Section: Introductionmentioning

confidence: 99%

RP-HPLC Method Development and Validation for an Estimation of Empaglifl ozin from Bulk and Pharmaceutical Dosage Form

Avinash¹,

Gandhimathi²

2023

IJPQA

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The objective of a recent investigation was to develop an RP-HPLC technique for assessing empaglifl ozin in both bulks and pharmaceutical dosage forms. An Agilent Eclipse XDE C-18 (4.6 mm x 250 mm, 5.0 m particle size) column for separation, a mobile phase of 0.1 M TEA pH 5.5 corrected by methanol and OPA in a proportion of 4:96 percent v/v at a fl ow rate of 0.7 mL/minwas utilized towards achieving the desired peak resolution. Diagonal array detectors (DADs) are utilized to measure the eluent at a wavelength of 270 nm. The regression equations for empaglifl ozin in bulk were y = 58.924x-5.693 and the regression equations for empaglifl ozin in tablet dosage form were y=57.927x+5.027. The calibration curve shows that the peak size was proportionate toward the concentration. In the precision study, the % of the amount was found in the 100 to 101% range. In %accuracy, %RSD was found to be 99.18 to 99.84 for empaglifl ozin in bulk and 99.29 to 99.53 for empaglifl ozin in the tablet dosage form. The limit of detection (LoD) for empaglifl ozin was determined to be 0.309143 μg/mL, while the limit of quantitation (LoQ) was determined in the direction of 0.936798 μg/mL. Based on the fi ndings of the robustness experiments, it was determined that the method’s accuracy and specifi city remain within acceptable ranges when subjected to minor adjustments to fl ow rate, wavelength, and mobile phase. The established technique was suitable for use in quality control labs to determine the quantity of empaglifl ozin present in bulk and tablet formulation

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Section: Introductionmentioning

confidence: 99%

RP-HPLC Method Development and Validation for an Estimation of Empaglifl ozin from Bulk and Pharmaceutical Dosage Form

Avinash¹,

Gandhimathi²

2023

IJPQA

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Development and validation of thin-layer chromatography and high-performance thin-layer chromatography methods for the simultaneous determination of linagliptin and empagliflozin in their co-formulated dosage form

Rizk

Attia

Mohamed

et al. 2020

JPC-J Planar Chromat

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Economic Spectrofluorometric Bioanalysis of Empagliflozin in Rats’ Plasma

Ayoub

Zahar

Michel

et al. 2021

Journal of Analytical Methods in Chemistry

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A simple, economic, green, and sensitive bioanalytical method for empagliflozin bioassay in rats’ plasma was employed successfully owing to the empagliflozin native fluorescence behavior. Enhanced liquid-liquid extraction, using diethyl ether (DEE), was successfully employed for the improved extraction of empagliflozin from rats’ plasma based on its high value of logP as 1.8 that boosted the drug migration from plasma to the organic layer. The relative fluorescence intensity for empagliflozin was recorded at emission (299.4 nm) after excitation at 226.5 nm. The method was validated with satisfactory results for linearity (500–5000 ng/mL), trueness, precision, the matrix effect, and extraction recovery. The matrix effect ranged between 15.63% and 23.10% for LQC and HQC samples, respectively. Extraction recovery ranged between 54.61% and 62.54% for LQC and HQC samples, respectively. Bias values for the trueness ranged between −10.62 and +14.95, while %RSD values for the precision ranged between 5.39% and 9.33%. The method was successfully applied to rats’ plasma samples that included six rats, and the drug concentration was determined in their plasma after 1 hour (estimated Cmax based on literature) following oral administration of empagliflozin with a concentration of 10 mg/Kg, p.o.. The developed cost-effective spectrofluorimetric method in the present work will be of beneficial use in further pharmacokinetic studies that include rats’ plasma and biological fluids. Moreover, with the suitable modifications, the described novel extraction of empagliflozin could be adopted to human plasma samples and future clinical studies. Moreover, development of new simple cost-effective methods is necessary to give the researchers a set of “varieties” that they can use according to the laboratory limitations, especially in the developing countries in addition of being a greener method due to the lower consumption of toxic solvents and lower waste production.

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Rp-HPLC Method Development and Validation for Simultaneous Estimation of Linagliptin and Empagliflozin

Cited by 6 publications

References 11 publications

RP-HPLC Method Development and Validation for an Estimation of Empaglifl ozin from Bulk and Pharmaceutical Dosage Form

RP-HPLC Method Development and Validation for an Estimation of Empaglifl ozin from Bulk and Pharmaceutical Dosage Form

Development and validation of thin-layer chromatography and high-performance thin-layer chromatography methods for the simultaneous determination of linagliptin and empagliflozin in their co-formulated dosage form

Economic Spectrofluorometric Bioanalysis of Empagliflozin in Rats’ Plasma

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