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Abstract
To develop a simple, accurate, precise, and rapid analytical method validation for stability-indicating RP-UPLC method for the simultaneous estimation of Metformin, Dapagliflozin, and Saxagliptin in bulk and tablet dosage form. The separation was carried out on CHS C18 (100 x 2.1 mm) 1.7 µm column, with the mobile phase composition of Water: Methanol (50:50 v/v). Flow rate: 0.3 mL/min. UV detection was carried out at 222 nm. The developed method was validated for linearity, accuracy, precision, the limit of detection, and quantification as per ICH guidelines. The linearity of the drugs from the concentration range of 5-30 µg/mL was established by constructing the calibration curve with a concentration on the X-axis and peak area on the Y-axis with the correlation coefficient of 0.999. The retention time of Metformin, Dapagliflozin, and Saxagliptin was found to be 1.060 min, 1.502 min, and 2.176 min. The %RSD of system precision for Metformin, Dapagliflozin, and Saxagliptin was found to be 1.0, 0.7, and 0.7, respectively. The %RSD of method precision for Metformin, Dapagliflozin, and Saxagliptin was found to be 0.7, 0.7, and 0.8, respectively. Percentage recovery was obtained as 99.63%, 100.26%, and 99.78% for Metformin, Dapagliflozin, and Saxagliptin, respectively. A new simple analytical method has been developed for the Simultaneous Estimation Of Metformin, Dapagliflozin and Saxagliptin in Bulk and Tablet Dosage Form.
References
Abdelrahman AE, Maher HM, Alzoman NZ. (2020) HPTLC method for the determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceuticals. Curr Anal Chem 16(5):609-619. DOI: https://doi.org/10.2174/1573407215666190131123029
Surendran S, Paul D, Pokharkar S, Deshpande A, Giri S, Satheeshkumar N. (2019) A LC-MS/MS method for simultaneous estimation of a novel anti-diabetic combination of Saxagliptin and Dapagliflozin using a polarity switch approach: Application to in vivo rat pharmacokinetic study. Anal Methods 11(2):219-226. DOI: https://doi.org/10.1039/C8AY02087F.
El-Shoubashy OH, Beltagy YA, Issa AE, El-Kafrawy DS. (2020) Comparative study of HPLC-DAD and HPTLC for the simultaneous determination of a new multitarget antidiabetic ternary mixture in combined tablets. J Planar Chromatogr - Mod TLC 33:59–70. DOI: https://doi.org/10.1007/s00764-019-00003-1.
Suthar AM, Prajapati LM, Joshi AK, Patel JR, Kharodiya ML, Prajapati LM. (2018) Estimation of Saxagliptin hydrochloride and Dapagliflozin propendiol monohydrate in combined dosage form. JIAPS 3(2):01-07.
Gundala A, Prasad KV, Koganti B. (2019) Application of quality by design approach in RP-HPLC method development for simultaneous estimation of saxagliptin and dapagliflozin in tablet dosage form. Braz J Pharm Sci 55: DOI: https://doi.org/10.1590/s2175-97902019000218129.
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