Method Development, Validation and Stress Studies of Dapagliflozin and Metformin Hydrochloride Using Ultraviolet-Visible Spectroscopy in Bulk and Combined Pharmaceutical Formulations

Bhavyasri, Khagga

doi:10.21786/bbrc/13.4/53

Cited by 4 publications

(2 citation statements)

References 5 publications

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“…Many analytical methods have been published for the estimation of DGZ alone or in combined state with other antidiabetic agents in pharmaceutical dosage form includes lonely UV spectroscopic method 12 , with other drug UV spectroscopic method [13][14][15][16] , HPLC method 17,18 , stability indicating HPLC [19][20][21][22] , QbD bio analytical 23 UHPLC bio analytical 24 , kinetic study UHPLC method 25 , stability indicating UPLC method 26 , UPLC DAD bio analytical 27 , LC-MS/MS bio analytical method [28][29][30] and critical review on bio analytical 31 . 10 and is proton pump inhibitor, suppresses secretion of gastric acid by inhibiting the enzyme system of H/K ATPase the proton pump of the gastric parietal cells.…”

Section: Introductionmentioning

confidence: 99%

Sustainable Green Analytical Chemistry: Spectrophotometric Method Development of Dapagliflozin and Omeprazole by Using Eco-Friendly Solvent

JADHAV,

BHILARE,

CHANDANSHIVE

et al. 2024

Curr. Res. Pharm. Sci.

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The present research’s aim was to develop analytical method utilizing ecologically suitable solvent which enhances solubility of analyte, sensitivity of the method etc. An analytical method was developed for the estimation of dapagliflozin (DGZ) and omeprazole (OPZ) by using aqueous 0.1 N HCl on the UV-VIS spectrophotometer. Wavelengths 223 nm and 282.5 nm were set to measure absorbance of DGZ and OPZ respectively. The results of different spectral characteristic techniques were examined to select the parameters and the design was validated against the ICH Q 2 R1 regulatory guidelines. The linearity of the drug was determined at a concentration of 1 to 50μg/ml and 1 to 32μg/ml for DGZ and OPZ respectively. The accuracy was found within acceptable limit with standard deviation 1.1874 to 6.4984 for DGZ and 0.1401 to 0.9843 for OPZ; and the assay study data was found 99.77 % for DGZ and 97.92 % for OPZ. The stability study of the method was performed out by minute variation in the wavelength, scan speed. The developed method is rigid, robust and efficient for the estimation of DGZ and OPZ from their respective dosage form. The effort was made to develop green or eco-friendly analytical method utilizing hydrotropic solvent for water insoluble drug dapagliflozin and omeprazole. KEYWORDS: Green method, Dapagliflozin, Omeprazole, analytical method, eco-friendly solvent, UV spectroscopy.

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Section: Introductionmentioning

confidence: 99%

Sustainable Green Analytical Chemistry: Spectrophotometric Method Development of Dapagliflozin and Omeprazole by Using Eco-Friendly Solvent

JADHAV,

BHILARE,

CHANDANSHIVE

et al. 2024

Curr. Res. Pharm. Sci.

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“…Now a day, stability indicating method as important regulatory and CGMP point of view to assess the drug stability. In the present study, it was tired to develop stability indicating RP-HPLC method to determine possible degradation products of DAPA and MET [18][19][20][21][22][23][24][25].…”

Section: Introductionmentioning

confidence: 99%

Stability Indicating HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin and Metformin Tablet Dosage Form

NANDRE¹,

AHMED²,

GJ³

2022

Asian J Pharm Clin Res

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Objectives: The objective of this study was to developed and validated for the routine analysis of dapagliflozin (DAPA) and metformin (MET) in API and tablet dosage forms. Methods: The estimation of DAPA and MET was accomplished with C18 column (4.6 × 250 mm and 5 μm particle size) with DAD detector. The mobile phase consists of Methanol: Water 75:25% v/v of pH-3 adjusted with 0.05% OPA at flow rate of 1 mL/min. The detection wavelength was 233nm, respectively. Results: In the developed method, the retention time of DAPA and MET was found to be 5.099 min and 2.165 min. The reverse phase high performance liquid chromatography method produces linear response that were found in the range of 100–500 μg/mL. The limit of detection and limit of quantification for DAPA were found to be 0.06 μg/mL and 0.1855 μg/mL, respectively and for MET 6.09 μg/mL and 18.45 μg/mL, respectively. Calculated information acquired for both the preliminaries roughly coordinates with the information given by design expert programming which shows the genuineness of the chromatographic condition. Conclusion: The developed method was validated according to the ICH guidelines. The linearity, precision, range, and robustness were within the limits as specified by the ICH guidelines. Hence, the method was found to be simple, accurate, precise, economic, and reproducible.

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A Comprehensive and Critical Review on Analytical and Bioanalytical methods for Metformin Hydrochloride, Dapagliflozin, and Saxagliptin

Desai

Maradia

Suhagia

2023

CPA

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New antidiabetic drug combination Metformin Hydrochloride, Dapagliflozin, and Saxagliptin have been recently approved for type II diabetes. This is marketed by Takeda Pharmaceuticals under the brand name Qternmet XR. Although different analytical and bioanalytical methods using different techniques such as liquid chromatography, high-performance liquid chromatography, high-performance thin-layer chromatography, gas chromatography, spectrophotometry, spectrofluorimetric methods coupled with ultraviolet, fluorescence, mass, or tandem-mass spectrometry detection have already been developed for the determination of Metformin Hydrochloride, Dapagliflozin, and Saxagliptin. Sensitive, cost-effective, and more optimized methods are yet required. Therefore, this review summarizes the main analytical and bioanalytical aspects regarding not only simultaneous estimation but also stability-indicating methods, kinetic studies, and impurity analysis for the analysis of proposed drugs in bulk and pharmaceutical dosage forms. Thus, this review gathers, for the first time, important background information on all analytical and bioanalytical methods that have been developed and applied for the determination of Metformin Hydrochloride, Dapagliflozin, and Saxagliptin, which should be considered as a starting point if new techniques are aimed to be implemented for these drugs.

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Method Development, Validation and Stress Studies of Dapagliflozin and Metformin Hydrochloride Using Ultraviolet-Visible Spectroscopy in Bulk and Combined Pharmaceutical Formulations

Cited by 4 publications

References 5 publications

Sustainable Green Analytical Chemistry: Spectrophotometric Method Development of Dapagliflozin and Omeprazole by Using Eco-Friendly Solvent

Sustainable Green Analytical Chemistry: Spectrophotometric Method Development of Dapagliflozin and Omeprazole by Using Eco-Friendly Solvent

Stability Indicating HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin and Metformin Tablet Dosage Form

A Comprehensive and Critical Review on Analytical and Bioanalytical methods for Metformin Hydrochloride, Dapagliflozin, and Saxagliptin

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