HPLC Estimation of New Impurity Methyl Ezetimibe in Ezetimibe Drug

Duggirala Parvatha Venkata Vardhani Devi; Kapavarapu Maruthi Venkata Narayanarao; Pulipaka Shyamala; Rallabhandi Murali Krishna; Komali Siva Prasad

doi:10.14233/ajchem.2020.22533

Issue

Vol. 32 No. 6 (2020): Vol 32 Issue 6

Issue Published : May 30, 2020

This work is licensed under a Creative Commons Attribution 4.0 International License.

HPLC Estimation of New Impurity Methyl Ezetimibe in Ezetimibe Drug

https://doi.org/10.14233/ajchem.2020.22533

Duggirala Parvatha Venkata Vardhani Devi

G.V.K. Biosciences Pvt. Ltd., Plot No. 28 A, IDA Nacharam, Hyderabad-500076, India

Kapavarapu Maruthi Venkata Narayanarao

G.V.K. Biosciences Pvt. Ltd., Plot No. 28 A, IDA Nacharam, Hyderabad-500076, India

Pulipaka Shyamala

Department of Physical and Nuclear Chemistry, Andhra University, Visakhapatnam-530003, India

Rallabhandi Murali Krishna

Department of Chemical Oceanography, Andhra University, Visakhapatnam-530003, India

Komali Siva Prasad

G.V.K. Biosciences Pvt. Ltd., Plot No. 28 A, IDA Nacharam, Hyderabad-500076, India

Corresponding Author(s) : Duggirala Parvatha Venkata Vardhani Devi

dhanimaruthi@gmail.com

Asian Journal of Chemistry, Vol. 32 No. 6 (2020): Vol 32 Issue 6
Article Published : May 30, 2020

Abstract

A new gradient elution mode HPLC method was developed and validated to detect and monitor the novel impurity namely methyl ezitimibe in ezetimibe drug substances. Chromatographic detection and analysis of methyl ezetimibe was performed on XBridge C18 column with mobile phase consisting of 0.02 M phosphate buffer (pH 5) and acetonitrile with 1 mL/min flow rate in gradient elution mode. Methyl ezetimibe was detected and monitored at 248 nm. The calibration curve was linear over range of 0.015 to 0.219% concentration. The limit of detection and quantification were computed as 0.005% (signal to noise ratio 3.60) and 0.015% (signal to noise ratio 15.96), respectively. The precision was 0.97% (%RSD) and accuracy was 93.2 to 98.2% (recovery). The developed method was proved suitable to detect and monitor methyl ezetimibe impurity in ezetimibe drug substances.

Keywords

Methyl ezetimibe Ezetimibe Impurity HPLC

Vardhani Devi, D. P. V., Venkata Narayanarao, K. M., Shyamala, P., Krishna, R. M., & Prasad, K. S. (2020). HPLC Estimation of New Impurity Methyl Ezetimibe in Ezetimibe Drug. Asian Journal of Chemistry, 32(6), 1309–1313. https://doi.org/10.14233/ajchem.2020.22533

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References

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C. Gagné, H.E. Bays, S.R. Weiss, P. Mata, K. Quinto, M. Melino, M. Cho, T.A. Musliner and B. Gumbine, Am. J. Cardiol., 90, 1084 (2002); https://doi.org/10.1016/s0002-9149(02)02774-1

A.C. Goldberg, A. Sapre, J. Liu, R. Capece and Y.B. Mitchel, Mayo Clin. Proc., 79, 620 (2004); https://doi.org/10.4065/79.5.620

J.R. Guyton, D.J. Betteridge, M. Farnier, L.A. Leiter, J. Lin, A. Shah, A.O. Johnson-Levonas and P. Brudi, Diab. Vasc. Dis. Res., 8, 160 (2011); https://doi.org/10.1177/1479164111406457

H.E. Bays, L. Ose, N. Fraser, D.L. Tribble, K. Quinto, R. Reyes, A.O. Johnson-Levonas, A. Sapre and S.R. Donahue. Clin. Ther., 26, 1758 (2004); https://doi.org/10.1016/j.clinthera.2004.11.016

I.V. Sunil Kumar, G.S.R. Anjaneyulu and V. Hima Bindu, Beilstein J. Org. Chem., 7, 29 (2011); https://doi.org/10.3762/bjoc.7.5

C.S. Wu, Z.X. Jia, B.M. Ning, J.L. Zhang and S. Wu, Chin. Chem. Lett., 23, 1185 (2012); https://doi.org/10.1016/j.cclet.2012.09.001

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Guidance for industry Q3A (R2), Impurities in New Drug Substances, In: International Conference on Harmonization (2006).

Guidance for Industry Q3B (R2), Impurities in New Drug Products, In: International Conference on Harmonization (2006).

K. Filip, K. Bañkowski, K. Sidoryk, J. Zagrodzka, M. £aszcz, K. Trzciñska, A. Szyprowska, P. Cmoch and W. Maruszak, J. Mol. Struct., 991, 162 (2011); https://doi.org/10.1016/j.molstruc.2011.02.020

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S. Guntupalli, U.K. Ray, N. Murali, P.B. Gupta, V.J. Kumar, D. Satheesh and A. Islam, J. Pharm. Biomed. Anal., 88, 385 (2014); https://doi.org/10.1016/j.jpba.2013.09.020

Y. Ren, Y.J. Duan, R.J. Li, Y. Deng, L. Hai and Y. Wu, Chin. Chem. Lett., 25, 1157 (2014); https://doi.org/10.1016/j.cclet.2014.03.035

A.E. Bellur and B. Karliga, J. Pharm. Anal., 5, 356 (2015); https://doi.org/10.1016/j.jpha.2015.04.002

ICH Expert Working Group. Validation of Analytical Procedures: Text and Methodology Q2 (R1) (2005).

Issue

Vol. 32 No. 6 (2020): Vol 32 Issue 6

HPLC Estimation of New Impurity Methyl Ezetimibe in Ezetimibe Drug

Corresponding Author(s) : Duggirala Parvatha Venkata Vardhani Devi

Abstract

Keywords

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