A Comprehensive Review on Analytical Method Development and Validation for SGLT-2 Inhibitors by HPLC in Its API and Dosage Form

Munde, Manojkumar K.; Kulkarni, Nilesh S.; Rukhe, Nikita B.; Sen, Dhanya B.

doi:10.5958/0974-360x.2020.00616.2

Cited by 6 publications

(1 citation statement)

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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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Stability Indicating and Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin in Tablet dosage form using RP-HPLC

Kandula

Sundararajan

2021

RJPT

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Aim: To Perform Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin Tablet dosage form developed in a simple, Accurate, precise manner. Method: Agilent C18 150 x 4.6mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1.0 ml/min used for the development of chromatogram. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 260nm. Results and Conclusion: Retention time of Saxagliptin, Dapagliflozin and Metformin were found to be 2.253 min, 2.720 min, 3.276 min respectively. % RSD of the Saxagliptin, Dapagliflozin and Metformin were and found to be 0.8, 0.2 and 0.6. % Recovery was obtained as 99.60%, 100.07% and 99.95% for Saxagliptin, Dapagliflozin and Metformin respectively. LOD, LOQ values obtained from regression equations of Saxagliptin, Dapagliflozin and Metformin were 0.06, 0.12, 9.61 and 0.17, 0.36, 29.31 respectively. Regression equation of Saxagliptin is y = 40882x + 889.2, Dapagliflozin is y = 47904x + 3897 and Metformin is y = 4530.x + 35785. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

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Validated Method development for estimation of Sofosbuvir and Daclatasvir in bulk and their dosage form by using RP-HPLC

Yamana

Bonnoth

2022

RJPT

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A simple, Accurate, precise method was developed for the simultaneous estimation of the Sofosbuvir and Daclatasvir in Tablet dosage form. Chromatogram was run through Standard Ascentis C18 150 x 4.6mm, 5m. Mobile phase containing Acetonitrile: Water taken in the ratio 60:40 was pumped through column at a flow rate of 0.7ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 279nm. Retention time of Sofosbuvir and Daclatasvir were found to be 2.198 min and 2.765 min. %RSD of the Sofosbuvir and Daclatasvir were and found to be 0.4 and 0.3 respectively. %Recovery was obtained as 99.88% and 99.80% for Sofosbuvir and Daclatasvir respectively. LOD, LOQ values obtained from regression equations of Sofosbuvir and Daclatasvir were 1.73, 5.23 and 0.12, 0.36 respectively. Regression equation of Sofosbuvir is y = 9010x+ 21702, and y = 10136x+1757 of Daclatasvir Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

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A Comprehensive Review on Analytical Method Development and Validation for SGLT-2 Inhibitors by HPLC in Its API and Dosage Form

Cited by 6 publications

References 0 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

Stability Indicating and Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin in Tablet dosage form using RP-HPLC

Validated Method development for estimation of Sofosbuvir and Daclatasvir in bulk and their dosage form by using RP-HPLC

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