Development and validation of stability indicating reversed-phase hplc method for the determination of ezetimibe in pharmaceutical dosage forms

S. Pandey, M. Rathanand

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6 Citations (Scopus)

Abstract

In the present study, a simple, rapid and precise liquid chromatographic method was developed and validated for the determination of ezetimibe in its dosage form. The Ezetimibe was separated in a 100 × 4.6 mm i.d., C18 column, 3 μm particle sizes, Luna phenomenex, using a mobile phase composition of water and acetonitrile (60:40 v/v). Column oven temperature was kept at 25°C.The flow rate was 1.5 mL/min and the analyte monitored at 225 nm. The retention time of Ezetimibe was 8.47 min. The specificity of the method was determined by assessing interference from the placebo and by stress testing of the drug (forced degradation).The developed method was validated in terms of linearity, accuracy, precision, system suitability, limit of detection, limit of quantitation and solution stability. The proposed method was also applied successfully to the pharmaceutical dosage form self emulsified drug delivery without any interference by excipients.
Original languageEnglish
Pages (from-to)53-57
Number of pages5
JournalInternational Journal of Pharmaceutical Sciences Review and Research
Volume1
Issue number1
Publication statusPublished - 2010

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Dosage Forms
Pharmaceutical Preparations
Excipients
Particle Size
Limit of Detection
Placebos
Temperature
Ezetimibe
Water

Cite this

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title = "Development and validation of stability indicating reversed-phase hplc method for the determination of ezetimibe in pharmaceutical dosage forms",
abstract = "In the present study, a simple, rapid and precise liquid chromatographic method was developed and validated for the determination of ezetimibe in its dosage form. The Ezetimibe was separated in a 100 × 4.6 mm i.d., C18 column, 3 μm particle sizes, Luna phenomenex, using a mobile phase composition of water and acetonitrile (60:40 v/v). Column oven temperature was kept at 25°C.The flow rate was 1.5 mL/min and the analyte monitored at 225 nm. The retention time of Ezetimibe was 8.47 min. The specificity of the method was determined by assessing interference from the placebo and by stress testing of the drug (forced degradation).The developed method was validated in terms of linearity, accuracy, precision, system suitability, limit of detection, limit of quantitation and solution stability. The proposed method was also applied successfully to the pharmaceutical dosage form self emulsified drug delivery without any interference by excipients.",
author = "S. Pandey and M. Rathanand",
note = "Cited By :6 Export Date: 10 November 2017 Correspondence Address: Pandey, S.; MCOPS, Manipal, Manipal University, Udupi Karnataka, India; email: dot.shivanand@gmail.com Chemicals/CAS: ezetimibe, 163222-33-1 Manufacturers: Glenmark, India References: Heek, M.V., France, C.F., Compton, D.S., McLeod, R.L., Yumibe, N.P., Alton, K.B., Sybertz, E.J., Davis Jr., H.R., (1997) Pharmacol. Exp. Ther., 283, pp. 157-163; Knoop, R.H., Bays, H., Manion, C.V., Lipka, L.J., Melani, L., LeBeaut, A.P., Suresh, R., Veltri, E.P., Proceedings of the 72nd EAS Congress, pp. 175+90. , Posters; Davis, H.R., (2004) International Congress Series, 1262, pp. 243-246; Patrick, J.E., Kosoglou, T., Stauber, K.L., Alton, K.B., Maxwell, S.E., Zhu, Y., Statkevich, P., Cayen, M.N., (2002) Drug Metab. Dispos, 30, pp. 430-437; Heek, M.V., Farley, C., Compton, D., Hoos, L., Alton, K., Sybertz, E., Davis, H., Proceedings of the 12th International Symposium on Atherosclerosis, , Tu T3 W16 (Abstract); Ballantyne, C.M., (2002) Eur. Heart J., 4 (SUPPL. J), pp. J9; Ballantyne, C.M., Houri, J., Notarbartolo, A., Melani, L., Lipka, L.J., Suresh, R., Sun, S., Veltri, E.P., (2003) Circulation, 107, pp. 2409-2415; Davidson, M.H., McGarry, T., Bettis, R., Melani, L., Lipka, L.J., LeBeaut, A.P., Suresh, R., Veltri, E.P., (2002) J. Am. Coll. Cardiol, 40, pp. 2125-2134; Kerzner, B., Corbelli, J., Sharp, S., Lipka, L.J., Melani, L., LeBeaut, A., Suresh, R., Veltri, E.P., (2003) Am. J. Cardiol, 91, pp. 418-424; Melani, L., Mills, R., Hassman, D., Lipetz, R., Lipka, L., LeBeaut, A., Suresh, R., Veltri, E.P., (2003) Eur. Heart J, 24, pp. 717-728; (2005), http://www.rxlist.com/cgi/generic/ezetimibe.htm, (accessed on 12.08.2009); Ezzet, F., Krishna, G., Wexler, D.B., Statkevich, P., Kosoglou, T., Batra, V.K., (2001) Clin. Therap, 23, pp. 871-885; (2006) International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, , ICH, Q2 (R), Geneva, Switzerland; Sistla, R., Tata, V.S.S.K., Kashyap, Y.V., Chandrasekar, D., Diwan, P.V., (2005) J Pharm Biomed Anal, 39, pp. 517-522; (2007) United States pharmacopoeia, , USP, 30th edn. United States Pharmacopeial Convention, Rockville; Shabir, G.A., (2003) J. Chromatogr. A, 987, pp. 57-59; Validation of analytical procedures: Methodology, , ICH Topic Q2R, (CPMP/ICH/281/95); Ermer, J., (2001) J. Pharm. Biomed. Anal, 24, pp. 755-767",
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TY - JOUR

T1 - Development and validation of stability indicating reversed-phase hplc method for the determination of ezetimibe in pharmaceutical dosage forms

AU - Pandey, S.

AU - Rathanand, M.

N1 - Cited By :6 Export Date: 10 November 2017 Correspondence Address: Pandey, S.; MCOPS, Manipal, Manipal University, Udupi Karnataka, India; email: dot.shivanand@gmail.com Chemicals/CAS: ezetimibe, 163222-33-1 Manufacturers: Glenmark, India References: Heek, M.V., France, C.F., Compton, D.S., McLeod, R.L., Yumibe, N.P., Alton, K.B., Sybertz, E.J., Davis Jr., H.R., (1997) Pharmacol. Exp. Ther., 283, pp. 157-163; Knoop, R.H., Bays, H., Manion, C.V., Lipka, L.J., Melani, L., LeBeaut, A.P., Suresh, R., Veltri, E.P., Proceedings of the 72nd EAS Congress, pp. 175+90. , Posters; Davis, H.R., (2004) International Congress Series, 1262, pp. 243-246; Patrick, J.E., Kosoglou, T., Stauber, K.L., Alton, K.B., Maxwell, S.E., Zhu, Y., Statkevich, P., Cayen, M.N., (2002) Drug Metab. Dispos, 30, pp. 430-437; Heek, M.V., Farley, C., Compton, D., Hoos, L., Alton, K., Sybertz, E., Davis, H., Proceedings of the 12th International Symposium on Atherosclerosis, , Tu T3 W16 (Abstract); Ballantyne, C.M., (2002) Eur. Heart J., 4 (SUPPL. J), pp. J9; Ballantyne, C.M., Houri, J., Notarbartolo, A., Melani, L., Lipka, L.J., Suresh, R., Sun, S., Veltri, E.P., (2003) Circulation, 107, pp. 2409-2415; Davidson, M.H., McGarry, T., Bettis, R., Melani, L., Lipka, L.J., LeBeaut, A.P., Suresh, R., Veltri, E.P., (2002) J. Am. Coll. Cardiol, 40, pp. 2125-2134; Kerzner, B., Corbelli, J., Sharp, S., Lipka, L.J., Melani, L., LeBeaut, A., Suresh, R., Veltri, E.P., (2003) Am. J. Cardiol, 91, pp. 418-424; Melani, L., Mills, R., Hassman, D., Lipetz, R., Lipka, L., LeBeaut, A., Suresh, R., Veltri, E.P., (2003) Eur. Heart J, 24, pp. 717-728; (2005), http://www.rxlist.com/cgi/generic/ezetimibe.htm, (accessed on 12.08.2009); Ezzet, F., Krishna, G., Wexler, D.B., Statkevich, P., Kosoglou, T., Batra, V.K., (2001) Clin. Therap, 23, pp. 871-885; (2006) International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, , ICH, Q2 (R), Geneva, Switzerland; Sistla, R., Tata, V.S.S.K., Kashyap, Y.V., Chandrasekar, D., Diwan, P.V., (2005) J Pharm Biomed Anal, 39, pp. 517-522; (2007) United States pharmacopoeia, , USP, 30th edn. United States Pharmacopeial Convention, Rockville; Shabir, G.A., (2003) J. Chromatogr. A, 987, pp. 57-59; Validation of analytical procedures: Methodology, , ICH Topic Q2R, (CPMP/ICH/281/95); Ermer, J., (2001) J. Pharm. Biomed. Anal, 24, pp. 755-767

PY - 2010

Y1 - 2010

N2 - In the present study, a simple, rapid and precise liquid chromatographic method was developed and validated for the determination of ezetimibe in its dosage form. The Ezetimibe was separated in a 100 × 4.6 mm i.d., C18 column, 3 μm particle sizes, Luna phenomenex, using a mobile phase composition of water and acetonitrile (60:40 v/v). Column oven temperature was kept at 25°C.The flow rate was 1.5 mL/min and the analyte monitored at 225 nm. The retention time of Ezetimibe was 8.47 min. The specificity of the method was determined by assessing interference from the placebo and by stress testing of the drug (forced degradation).The developed method was validated in terms of linearity, accuracy, precision, system suitability, limit of detection, limit of quantitation and solution stability. The proposed method was also applied successfully to the pharmaceutical dosage form self emulsified drug delivery without any interference by excipients.

AB - In the present study, a simple, rapid and precise liquid chromatographic method was developed and validated for the determination of ezetimibe in its dosage form. The Ezetimibe was separated in a 100 × 4.6 mm i.d., C18 column, 3 μm particle sizes, Luna phenomenex, using a mobile phase composition of water and acetonitrile (60:40 v/v). Column oven temperature was kept at 25°C.The flow rate was 1.5 mL/min and the analyte monitored at 225 nm. The retention time of Ezetimibe was 8.47 min. The specificity of the method was determined by assessing interference from the placebo and by stress testing of the drug (forced degradation).The developed method was validated in terms of linearity, accuracy, precision, system suitability, limit of detection, limit of quantitation and solution stability. The proposed method was also applied successfully to the pharmaceutical dosage form self emulsified drug delivery without any interference by excipients.

M3 - Article

VL - 1

SP - 53

EP - 57

JO - International Journal of Pharmaceutical Sciences Review and Research

JF - International Journal of Pharmaceutical Sciences Review and Research

SN - 0976-044X

IS - 1

ER -