Development and validation of a stability-indicating RP-LC method for the estimation of process-related impurities and degradation products of oxcarbazepine in pharmaceutical formulation

Czasopismo : Acta Chromatographica
Tytuł artykułu : Development and validation of a stability-indicating RP-LC method for the estimation of process-related impurities and degradation products of oxcarbazepine in pharmaceutical formulation

Autorzy :
Mansoor, S.
Georgia Institute of Technology School of Chemical and Biomolecular Engineering Atlanta GA 30332-0100 USA,
Tas, C.
Georgia Institute of Technology School of Chemical and Biomolecular Engineering Atlanta GA 30332-0100 USA, ctas@gata.edu.tr,
Patel, D. S.
Pramukh Swami Science and H.D. Patel Arts College Chemistry Department Sarva Vidyalaya Campus Kadi 382 715 Gujarat India,
Sharma, N.
BA Research India Ltd. Bio-Analytical Laboratory Bodakdev, Ahmedabad 380054 Gujarat India,
Patel, M. C.
Pramukh Swami Science and H.D. Patel Arts College Chemistry Department Sarva Vidyalaya Campus Kadi 382 715 Gujarat India,
Patel, B. N.
BA Research India Ltd. Bio-Analytical Laboratory Bodakdev, Ahmedabad 380054 Gujarat India, bhavinpatel27@rediffmail.com,
Shrivastav, P. S.
Gujarat University Department of Chemistry, School of Sciences Navrangpura, Ahmedabad 380009 Gujarat India, pranav_shrivastav@yahoo.com,
Sanyal, M.
St. Xavier’s College Department of Chemistry Navrangpura, Ahmedabad 380009 Gujarat India,
Wang, G. Y.
Chinese Academy of Sciences Key Laboratory of Chemistry of Northwestern Plant Resources and Key Laboratory for Natural Medicine of Gansu Province, Lanzhou Institute of Chemical Physics Lanzhou 730000 P. R. China,
Shi, Y. P.
Lanzhou University of Technology School of Petroleum and Chemical Engineering Lanzhou 730050 P. R. China, shiyp@licp.cas.cn,
Akowuah, G. A.
UCSI University Faculty of Applied Sciences No. 1, Jalan Menara Gading, UCSI Heights 56000 Kuala Lumpur Malaysia, wuahmy@yahoo.com,
Okechukwu, P. N.
UCSI University Faculty of Pharmaceutical Sciences No. 1, Jalan Menara Gading, UCSI Heights 56000 Kuala Lumpur Malaysia,
Chiam, N. C.
UCSI University Faculty of Pharmaceutical Sciences No. 1, Jalan Menara Gading, UCSI Heights 56000 Kuala Lumpur Malaysia,
Raszewski, G.
Institute of Agricultural Medicine Department of Pathophysiology Lublin Poland, grasz@galen.imw.lublin.pl,
Juszczak, M.
Institute of Agricultural Medicine Department of Medical Biology Lublin Poland,
Lemieszek, M. K.
Institute of Agricultural Medicine Department of Medical Biology Lublin Poland,
Matysiak, J.
University of Life Sciences Department of Chemistry Lublin Poland,
Niewiadomy, A.
University of Life Sciences Department of Chemistry Lublin Poland,
Rzeski, W.
Maria Curie-Sklodowska University Department of Virology and Immunology, Institute of Microbiology and Biotechnology Lublin Poland,
Reddy, P. S.
IPDO Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad 500072 A.P India, sunilpsr@yahoo.com,
Babu, K. S.
S. K. University Department of Chemistry Anantapur 515055 A.P. India,
Kumar, N.
IPDO Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad 500072 A.P India,
Abstrakty : A stability-indicating gradient reverse-phase liquid chromatographic method was developed for the quantitative determination of process-related impurities and forced degradation products of oxcarbazepine in pharmaceutical formulation. The method was developed by using Inertsil cyano (250 × 4.6 mm) 5 μm column with mobile phase containing a gradient mixture of solvent A (0.01 M sodium dihydrogen phosphate, pH adjusted to 2.7 with orthophosphoric acid and acetonitrile in the ratio of 80:20 v/v) and B (50:40:10 v/v/v mixture of acetonitrile, water, and methanol). The flow rate of mobile phase was 1.0 mL min−1. Column temperature was maintained at 25°C and detection wavelength at 220 nm. Developed reverse-phase high-performance liquid chromatography (RP-HPLC) method can adequately separate and quantitate five impurities of oxcarbazepine, namely imp-A, imp-B, imp-C, imp-D, and imp-E. Oxcarbazepine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Oxcarbazepine was found to degrade significantly in acid, base, and oxidative stress conditions. The degradation products were well resolved from oxcarbazepine and its impurities. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness.

Słowa kluczowe : development, validation, stability-indicating, LC-MS, degradation, oxcarbazepine,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2014
Numer : Vol. 26, no. 2
Strony : 267 – 282
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DOI :
Cytuj : Mansoor, S. ,Tas, C. ,Patel, D. S. ,Sharma, N. ,Patel, M. C. ,Patel, B. N. ,Shrivastav, P. S. ,Sanyal, M. ,Wang, G. Y. ,Shi, Y. P. ,Akowuah, G. A. ,Okechukwu, P. N. ,Chiam, N. C. ,Raszewski, G. ,Juszczak, M. ,Lemieszek, M. K. ,Matysiak, J. ,Niewiadomy, A. ,Rzeski, W. ,Reddy, P. S. ,Babu, K. S. ,Kumar, N. , Development and validation of a stability-indicating RP-LC method for the estimation of process-related impurities and degradation products of oxcarbazepine in pharmaceutical formulation. Acta Chromatographica Vol. 26, no. 2/2014
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