A Highly Validated Rp-HPLC Method Development for the Simultaneous Estimation of Dapagliflozin and Saxagliptin in Tablet Dosage Forms

Sivagami, B; Padmaja, B.; Babu, M. Niranjan

doi:10.25004/ijpsdr.2018.100503

Cited by 9 publications

(4 citation statements)

References 12 publications

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“…The analytical run duration for the proposed method is short (6 min); hence, this method was rapid and superior than literature methods [8,[11][12][13]. When compared with previous HPLC reports [14][15][16][17][18] for this drug combination, the proposed method has advantages such as high resolution (7.3) and wide linearity range (0.1-150 μg/mL, 0.2-300 μg/mL). Low LOD and LOQ values furnished in the method signify the high sensitivity over literature methods.…”

Section: Methods Comparison With Literature Methodsmentioning

confidence: 89%

“…Literature survey revealed that there were few reports published on the simultaneous quantification of dapagliflozin and saxagliptin using UV [8], HPTLC [9], HPLC [10][11][12][13][14][15][16][17][18], and LC-MS [19,20] techniques in bulk drug and pharmaceutical dosage forms. Few methods were reported for analysis of dapagliflozin and saxagliptin separately [21][22][23][24] and in combination with other drugs [25][26][27][28][29].…”

Section: Introductionmentioning

confidence: 99%

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Multivariate optimization of liquid chromatographic conditions for determination of dapagliflozin and saxagliptin, application to an in vitro dissolution and stability studies

et al. 2021

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Background Analytical quality by design driven HPLC method has been optimized for simultaneous estimation of dapagliflozin and saxagliptin in pharmaceutical dosage form. Response surface methodology was employed for optimization of experimental conditions using three factors such as organic phase (%), pH of aqueous phase, and flow rate of mobile phase. Results Virtuous separation of analytes was achieved with mobile phase consisted of acetonitrile: phosphate buffer, pH 5.8 (26:74% v/v) with flow rate 0.96 mL/min using SPOLAR C18 column (250 × 4.6 mm, 5 μ) with run time 6 min and UV detection at 236 nm. Retention time for dapagliflozin and saxagliptin were found to be 3.5 and 5.0 min, respectively. Method was validated as per ICH guidelines. The plot between peak area vs concentration for dapagliflozin and saxagliptin were rectilinear in the range of 0.2-300 μg/mL and 0.1-150 μg/mL respectively with detection and quantification limits were 0.061 and 0.18 μg/mL for dapagliflozin and 0.014 and 0.043 μg/mL for saxagliptin, respectively. Conclusion The proposed method was exploited for assay, in vitro dissolution, and stability studies of target drugs in marketed dosage form.

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Section: Methods Comparison With Literature Methodsmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Multivariate optimization of liquid chromatographic conditions for determination of dapagliflozin and saxagliptin, application to an in vitro dissolution and stability studies

et al. 2021

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“…The results of intraday and inter-day results were discussed Table 3. Repeatability: Six working sample solutions with the same concentrations were prepared and each injection from each working sample solution was given and obtained 9 .…”

Section: Methods Validationmentioning

confidence: 99%

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2022

IJPSR

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Fostemsavir was quantified using a simple and reliable HPLC technique developed and validated. PhenomenexC18 column was used to achieve chromatographic segregation (150 x 4.6 mm, 5m). The mobile phase was a 55:45 mixture of 0.01N disodium orthophosphate and acetonitrile pumped through the column at 1.0ml/min. The temperature was maintained at 30 °C and the buffer used was 0.01N sodium dihydrogen phosphate. The wavelength of the ideal choice was 278.0nm. Fostemsavir's retention time was discovered to be 2.471 minutes. Fostemsavir's percent RSD was found to be 0.7 percent. For Fostemsavir, the percentage recovery was 100.07 percent. Fostemsavir's regression equation yielded LOD and LOQ values of 0.18 and 0.54, respectively. Fostemsavir's regression equation is y = 26381x + 8398.8. Since run time and retention time were minimized, the system developed was simple and cost-effective, and it could be used on a daily basis for quality control.

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“…The Narendra Modi-led National Democratic Alliance (NDA) will have a strong majority in the Lok Sabha (national legislature) in the year 2020. (Prasad et al, 2015;Sivagami et al, 2018;Singh et al, 2018)…”

Section: Preparation Of Standard Solutionmentioning

confidence: 99%

Method Development and Validation of RP-HPLC method for Saxagliptin and Sitagliptin in Pharmaceutical Dosage Form - A Review

Suma

Cheriyan

Aanandhi

et al. 2021

ijrps

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The study's goal was to develop a plain, quick, and responsive RP-HPLC method for determining the concentrations of Saxagliptin and Sitagliptin in pharmaceutical bulk dosage form (bulk powders). Isocratic elution with Cosmosil C18 (250nm 4.6nm, 5m particle size) and UV detection at 212nm for Saxagliptin and Develosil ODS HG-5 RP-C18 (15cm 4.6mm, 5m particle size) and UV detection at 255nm for Sitagliptin were used in this chromatographic process. Methanol and water (70:30) in a mobile solution with a flow rate of 0.8ml/min for Saxagliptin and (0.05m) phosphate buffer: methanol and water (70:30) in a mobile solution with a flow rate of 0.8ml/min for Saxagliptin and (0.05m) phosphate buffer: These protocols have been put through their paces in accordance with ICH guidelines. The normal curves for Saxagliptin and Sitagliptin were observed to have a linear relationship across the analytical ranges of 10-50 g/ml and 30-70 g/ml, respectively. The accuracy, precision, limit of identification, the limit of quantification, and robustness of the system were all calculated. Various analytical methods such as UPLC (Ultra performance liquid chromatography), UV spectroscopy, LC-UV methods have performed to the quantitative determination of Saxagliptin and Sitagliptin drugs.

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A Highly Validated Rp-HPLC Method Development for the Simultaneous Estimation of Dapagliflozin and Saxagliptin in Tablet Dosage Forms

Cited by 9 publications

References 12 publications

Multivariate optimization of liquid chromatographic conditions for determination of dapagliflozin and saxagliptin, application to an in vitro dissolution and stability studies

Multivariate optimization of liquid chromatographic conditions for determination of dapagliflozin and saxagliptin, application to an in vitro dissolution and stability studies

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Method Development and Validation of RP-HPLC method for Saxagliptin and Sitagliptin in Pharmaceutical Dosage Form - A Review

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