Journal : Acta Chromatographica
Article : Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals

Authors :
Komsta, Ł.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland, lukasz.komsta@am.lublin.pl,
Gowin, E.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland,
Djordjević Filijović, N.
Hemofarm AD Vrsac Serbia,
Pavlović, A.
Hemofarm AD Vrsac Serbia,
Nikolić, K.
University of Belgrade, Faculty of Pharmacy Department of Pharmaceutical Chemistry Vojvode Stepe 450 PO Box 146 11000 Belgrade Serbia,
Agbaba, D.
University of Belgrade, Faculty of Pharmacy Department of Pharmaceutical Chemistry Vojvode Stepe 450 PO Box 146 11000 Belgrade Serbia, danica@pharmacy.bg.ac.rs,
Abstract : Aripiprazole is a novel atypical antipsychotic drug used in the treatment of schizophrenia. The sensitive and reproducible ion pair RPLC method was developed and validated for determination of aripiprazole and its nine impurities, which are significantly different in polarity. The separation was performed on Phenomenex Luna® C18 column (5.0 μm particle size, 250 × 4.6 mm id) using a gradient mobile phase A (phosphate buffer pH 3.0) and mobile phase B (acetonitrile) at the working temperature of 25°C. The buffer was 1.11 g KH2PO4 with 1.2 g sodium pentanesulfonate/L of the solution, adjusted to pH 3.0 with orthophosphoric acid. The flow rate was 1.0 mL/min. The detection was carried out at 215 nm using a diode array detector. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines for specificity, limit of detection, limit of quantification, linearity, precision and robustness. The proposed method is convenient and reliable for the purity control in both raw materials and dosage forms.

Keywords : aripiprazole, impurities, HPLC determination, method validation, purity assessment,
Publishing house : University of Silesia in Katowice
Publication date : 2014
Number : Vol. 26, no. 1
Page : 13 – 28

Bibliography
: 1 AHFS Drug Information, American Society of Health-System Pharmacists Bethesda, USA. 2008.
2 Katzung, B.G., Basic & Clinical Pharmacology, Antipsyhotic agents & Litium, Lange Medical Books/McGraw-Hill, San Francisco, USA, 2004.
3 Akamine, Y., Yasui-Furukori, N., Kojima, M., Inoue Y., Uno T., J Sep Sci., 33, 3292–3298 (2010).
4 Lancelin, F., Djebrani, K., Tabaouti, K., Kraoul, L., Brovedani, S., Paubel P., Piketty, M.L., J Chromatogr B Analyt Technol Biomed Life Sci., 867, 15–19 (2008).
5 Kirschbaum, K.M., Muller, M.J., Zernig, G., Saria, A., Mobascher, A., Malevani, J., Hiemke, C., Clin Chem., 51, 1718–1721 (2005).
6 Shimokawa, Y., Akiyama, H., Kashiyama, E., Koga, T., Miyamoto, G., J Chromatogr B Analyt Technol Biomed. Life Sci., 821, 8–14 (2005).
7 Musenga, A., Saracino, M.A., Spinelli, D., Rizzato, E., Boncompagni, G., Kenndler, E., Raggi, M.A., Anal. Chim. Acta, 612, 204–211 (2008).
8 Tsai, C.J., Yu, Y.H., Chiu, H.J., Lohel W, Wang, J.T., Chan, C.H., Lan, T.H, J. Chin. Med. Assoc., 74, 267–271 (2011).
9 Hwang, P.L., Wei, S.Y., Yeh, H.H., Ko, J.Y., Chang, C.C., Chen, S.H., Electrophoresis, 2010, 31, 2778–86.
10 Caloro, M., Lionetto, L., Cuomo, I., Simonetti, A., Pucci, D., De Persis, S., Casolla, B., Kotzalidis, G.D., Sciarretta, A., De Filippis, S., Simmaco, M., Girardi, P., J. Pharm. Biomed. Anal., 62, 135–139 (2012).
11 Choong, E., Rudaz, S., Kottelat, A., Guillarme, D., Veuthey, J.L., Eap. C.B., J. Pharm. Biomed. Anal., 50, 1000–1008 (2009).
12 Lin, S.N., Lamm, L., Newton, T.F., Reid, M.S., Moody, D.E., Foltz, A., J. Anal. Toxicol., 33, 237–242.
13 Song, M., Xu, X., Hang, T., Wen A., Yang. L., Anal Biochem., 385, 270–277 (2009).
14 Kubo, M., Mizooku, Y., Hirao, Y., Osumi, T., J. Chromatogr., B Analyt. Technol. Biomed. Life Sci., 822, 294–299 (2005).
15 Cong, Z.X., Wang, F., Xu, P., Rong-Xua, Z., Huan-De, L., Chromatographia, 64, 387–391 (2006).
16 Li, K.Y., Zhou, Y.G., Ren, H.Y., Wang, F., Zhang, B.K., Li, H.D., J. Chromatogr. B, Analyt. Technol. Biomed. Life Sci., 850, 581–585 (2007).
17 Huang, H.C., Liu, C.H., Lan, T.H., Hu, T.M., Chiu, H.J., Wu Y.C., Tseng, YL., J Chromatogr B Analyt Technol Biomed Life Sci., 856, 57–61 (2007).
18 Clinical Pharmacology and Biopharmaceutics Review(s), FDA Center for Drug Evaluation and Research, 2001. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify_biopharmr_P1.pdf
19 Patle, H.S., Chandewar, A.V., Kshirsagar, M.D., Int. J. Curr. Pharm. Res., 3, 59–61 (2011)
20 Kalaichelvi, R., Thangabalan, B., Srinivasa Rao, D., Jayachandran, E., E-J. Chem., 6, 87–S90 (2009)
21 Asangil, D., Tasdemir, H.I., Kılıc, E., J. Pharm. Anal., 2, 193–199 (2012)
22 Dedania, Z.R., Dedania, R., Sheth, N., Gajra, B., Patel, J., Asian J. Pharm. Biol. Res., 123–128 (2011).
23 Raveendra Babu, G., Srinivasa Rao, J., Suresh Kumar, K., Jayachandra Reddy, P., Asian J. Pharm. Ana., 1, 03–07 (2011).
24 Bhanotu, B., Srinath, P., Kedarnath, J., Int. J. Chem. Tech. Res., 4, 124–128 (2012).
25 Nerkar, P., Gide, P., Chitnis, A., Mahajan, H., Gattani, S., IJPSN, 2, 572–581 (2009).
26 Srinivas, K.S.V., Buchireddy, R., Madhusudhan, G., Mukkanti, K., Srinivasulu, P., Chromatographia, 68, 635–640 (2008)
27 Pai, N.R., Dubhashi, D.S., Der Pharmacia Lettre, 2, 1–10 (2010)
28 Reddy, G.V.R., Kumar, A.P., Reddy, B.V., Kumar, P., Gauttam, H.D., Eur. J. Chem., 1, 20–27 (2010)
29 ICH topic Q2 (R1), Validation of analytical procedures: text and methodology, adopted by CPMP, December 1996, issued as CPMP/ICH/281/95. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Qua lity/Q2_R1/Step4/Q2_R1__Guideline.pdf
DOI :
Qute : Komsta, Ł. ,Gowin, E. ,Djordjević Filijović, N. ,Pavlović, A. ,Nikolić, K. ,Agbaba, D. ,Agbaba, D. , Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals. Acta Chromatographica Vol. 26, no. 1/2014
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