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A Validated Stability Indicating High Performance Thin Layered Chromatographic Method for the Analysis of Dapagliflozin in Bulk Drug and Marketed Tablet Formulation
Corresponding Author(s) : Snehal R. Karmankar
Asian Journal of Chemistry,
Vol. 31 No. 7 (2019): Vol 31 Issue 7
Abstract
Present study reported the development of validated stability indicating high performance thin layer chromatography method for determination of dapagliflozin in bulk and tablet dosage form. Chromatography was performed on aluminium plates coated with silica gel 60F254 using methanol:toluene:ammonium acetate (6.9:3:0.1 v/v/v) as mobile phase. Densitometric analysis was performed at 250 nm. The method was validated with different parameters such as linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantitation (LOQ). The Rf value of dapagliflozin was found to be 0.29 ± 0.05. The method is sensitive (limit of quantification 50.5 ng band–1), precise (RSD ≤ 1.50 %), accurate (drug recovery 98.90-100.53 %) and linear over the range 100-1000 ng band–1 (r2 0.9985). The developed method was satisfactorily applied for the analysis of pharmaceutical preparations and found to be specific and accurate for quality control of the dapagliflozin in tablet dosage form.
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- E.C. Chao and R.R. Henry, Nat. Rev. Drug Discov., 9, 551 (2010); https://doi.org/10.1038/nrd3180.
- A.-F. Aubry, H. Gu, R. Magnier, L. Morgan, X. Xu, M. Tirmenstein, B. Wang, Y. Deng, J. Cai, P. Couerbe and M. Arnold, Bioanalysis, 2, 2001 (2010); https://doi.org/10.4155/bio.10.139.
- L. Van Gaal and A. Scheen, Diabetes Care, 38, 1161 (2015); https://doi.org/10.2337/dc14-1630.
- E.M. Vivian, Am. J. Health-Syst. Pharm., 72, 316 (2015); https://doi.org/10.2146/ajhp140168.
- ICH, Q2 (R1), Validation of Analytical Procedures: Text and Methodology, in: Proceedings of the International Conference on Harmonization, IFPMA, Geneva (2003).
- ICH, Q1A (R2), Stability Testing of New Drug Substances and Products, in: Proceedings of the International Conference on Harmonisation, IFPMA, Geneva (2003).
- ICH, Q1B, Stability Testing: Photostability Testing of New Drug Substances and Products, in: Proceedings of the International Conference on Harmonization, IFPMA, Geneva (2003).
- J. Debata, S. Kumar, S.K. Jha and A. Khan, Int. J. Drug Dev. Res., 9, 48 (2017).
- M. Sanagapati, K. Dhanalakshmi, N.G. Reddy and S. Sreenivasa, Int. J. Pharm. Sci. Drug Res., 6, 250 (2014).
- P.D. Patel and S.S. Pandya, Int. J. Pharm. Res. Scholars, 7, 9 (2018).
- M.D. Game and B. Naglaxmi, Int. J. Pharm. Drug Anal., 6, 84 (2018).
- M. Sanagapati, K. Dhanalakshmi, N.G. Reddy and S. Sreenivasa, J. Adv. Pharm. Educ. Res., 4, 350 (2014).
- M.V. Verma, C.J. Patel and M.M. Patel, Int. J. Appl. Pharm., 9, 33 (2017); https://doi.org/10.22159/ijap.2017v9i5.19185.
- S. A. Abdel-Gawad, A. M. S. Al-Tamim, E. H. K. Adam, Int. J. Bio. Pharm. Allied Sci., 6, 2007 (2017)
References
E.C. Chao and R.R. Henry, Nat. Rev. Drug Discov., 9, 551 (2010); https://doi.org/10.1038/nrd3180.
A.-F. Aubry, H. Gu, R. Magnier, L. Morgan, X. Xu, M. Tirmenstein, B. Wang, Y. Deng, J. Cai, P. Couerbe and M. Arnold, Bioanalysis, 2, 2001 (2010); https://doi.org/10.4155/bio.10.139.
L. Van Gaal and A. Scheen, Diabetes Care, 38, 1161 (2015); https://doi.org/10.2337/dc14-1630.
E.M. Vivian, Am. J. Health-Syst. Pharm., 72, 316 (2015); https://doi.org/10.2146/ajhp140168.
ICH, Q2 (R1), Validation of Analytical Procedures: Text and Methodology, in: Proceedings of the International Conference on Harmonization, IFPMA, Geneva (2003).
ICH, Q1A (R2), Stability Testing of New Drug Substances and Products, in: Proceedings of the International Conference on Harmonisation, IFPMA, Geneva (2003).
ICH, Q1B, Stability Testing: Photostability Testing of New Drug Substances and Products, in: Proceedings of the International Conference on Harmonization, IFPMA, Geneva (2003).
J. Debata, S. Kumar, S.K. Jha and A. Khan, Int. J. Drug Dev. Res., 9, 48 (2017).
M. Sanagapati, K. Dhanalakshmi, N.G. Reddy and S. Sreenivasa, Int. J. Pharm. Sci. Drug Res., 6, 250 (2014).
P.D. Patel and S.S. Pandya, Int. J. Pharm. Res. Scholars, 7, 9 (2018).
M.D. Game and B. Naglaxmi, Int. J. Pharm. Drug Anal., 6, 84 (2018).
M. Sanagapati, K. Dhanalakshmi, N.G. Reddy and S. Sreenivasa, J. Adv. Pharm. Educ. Res., 4, 350 (2014).
M.V. Verma, C.J. Patel and M.M. Patel, Int. J. Appl. Pharm., 9, 33 (2017); https://doi.org/10.22159/ijap.2017v9i5.19185.
S. A. Abdel-Gawad, A. M. S. Al-Tamim, E. H. K. Adam, Int. J. Bio. Pharm. Allied Sci., 6, 2007 (2017)