Journal : Acta Chromatographica
Article : A validated stability-indicating RP-LC method for the estimation of process-related impurities and degradation products of quetiapine fumarate in solid oral dosage form

Authors :
Huo, H. L.
Hebei Medical University Department of Pharmaceutical Analysis, School of Pharmacy Shijiazhuang 050017 China,
Yu, S. H.
Hebei Medical University Department of Pharmaceutical Analysis, School of Pharmacy Shijiazhuang 050017 China,
Liu, X. Z.
Hebei Medical University Department of Pharmaceutical Analysis, School of Pharmacy Shijiazhuang 050017 China,
Meng, Y.
Hebei Medical University Department of Pharmaceutical Analysis, School of Pharmacy Shijiazhuang 050017 China,
Ren, Y. P.
Hebei Medical University Department of Pharmaceutical Analysis, School of Pharmacy Shijiazhuang 050017 China,
Zhang, L. T.
Hebei Medical University Department of Pharmaceutical Analysis, School of Pharmacy Shijiazhuang 050017 China, zhanglantong@263.net,
Liu, L.
Laboratory for New Resources and Quality Evaluation of Chinese Medicines The MOE Key Laboratory for Standardization of Chinese Medicines and The SATCM Key 1200 Cailun Road, Zhangjiang Hi-Tech Park Shanghai 201210 China,
Zhao, T.
Laboratory for New Resources and Quality Evaluation of Chinese Medicines The MOE Key Laboratory for Standardization of Chinese Medicines and The SATCM Key 1200 Cailun Road, Zhangjiang Hi-Tech Park Shanghai 201210 China,
Cheng, X. M.
Laboratory for New Resources and Quality Evaluation of Chinese Medicines The MOE Key Laboratory for Standardization of Chinese Medicines and The SATCM Key 1200 Cailun Road, Zhangjiang Hi-Tech Park Shanghai 201210 China,
Wang, C. H.
Laboratory for New Resources and Quality Evaluation of Chinese Medicines The MOE Key Laboratory for Standardization of Chinese Medicines and The SATCM Key 1200 Cailun Road, Zhangjiang Hi-Tech Park Shanghai 201210 China, wchcxm@hotmail.com,
Wang, Z. T.
Laboratory for New Resources and Quality Evaluation of Chinese Medicines The MOE Key Laboratory for Standardization of Chinese Medicines and The SATCM Key 1200 Cailun Road, Zhangjiang Hi-Tech Park Shanghai 201210 China, wangzt@hotmail.com,
Gao, X.
Sichuan University Department of Clinical Pharmacy and Pharmacy Administration, West China School of Pharmacy Chengdu, Sichuan China, gaomuxouzi@126.com,
Jiang, X.
Sichuan University Department of Clinical Pharmacy and Pharmacy Administration, West China School of Pharmacy Chengdu, Sichuan China,
Wang, L.
Sichuan University Department of Clinical Pharmacy and Pharmacy Administration, West China School of Pharmacy Chengdu, Sichuan China,
Urban, J.
University of South Bohemia in Ceske Budejovice Faculty of Fisheries and Protection of Waters, South Bohemian Research Center of Aquaculture and Biodiversity of Hydrocenoses, School of Complex Systems (former Institute of Physical Biology), Laboratory of Applied System Biology Zamek 136 Nove Hrady 373 33 Czech Republic, urbanj@frov.jcu.cz,
Vaněk, J.
University of South Bohemia in Ceske Budejovice Faculty of Fisheries and Protection of Waters, South Bohemian Research Center of Aquaculture and Biodiversity of Hydrocenoses, School of Complex Systems (former Institute of Physical Biology), Laboratory of Applied System Biology Zamek 136 Nove Hrady 373 33 Czech Republic,
Štys, D.
University of South Bohemia in Ceske Budejovice Faculty of Fisheries and Protection of Waters, South Bohemian Research Center of Aquaculture and Biodiversity of Hydrocenoses, School of Complex Systems (former Institute of Physical Biology), Laboratory of Applied System Biology Zamek 136 Nove Hrady 373 33 Czech Republic,
Li, C. D.
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,
Liu, 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.
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, shiyp@licp.cas.cn,
Zhang, Y.
Sichuan University Department of Pharmaceutical and Biological Engineering Chengdu 610065 China, hangsong@vip.sina.com,
Peng, Q.
Sichuan University Department of Pharmaceutical and Biological Engineering Chengdu 610065 China,
Zeng, H.
Sichuan University Department of Pharmaceutical and Biological Engineering Chengdu 610065 China,
Yao, S.
Sichuan University Department of Pharmaceutical and Biological Engineering Chengdu 610065 China,
Zhang, Y.
Sichuan University Department of Pharmaceutical and Biological Engineering Chengdu 610065 China,
Song, H.
Sichuan University Department of Pharmaceutical and Biological Engineering Chengdu 610065 China,
Zhou, W.
Guiyang Medical University Department of Pharmaceutical Analysis, School of Pharmacy Guiyang 550004 China,
Zhang, X. Y.
Fudan University Department of Pharmaceutical Analysis, School of Pharmacy Shanghai 201203 China, drxyzhang@126.com,
Lv, Y. P.
Fudan University Department of Pharmaceutical Analysis, School of Pharmacy Shanghai 201203 China,
Liu, X. D.
Fudan University Department of Pharmaceutical Analysis, School of Pharmacy Shanghai 201203 China,
Xu, C.
Fudan University Department of Pharmaceutical Analysis, School of Pharmacy Shanghai 201203 China,
Duan, G. L.
Fudan University Department of Pharmaceutical Analysis, School of Pharmacy Shanghai 201203 China, glduan@shmu.edu.cn,
Smoliński, A.
Central Mining Institute Department of Energy Saving and Air Protection Sq. Gwarkow 1 40-166 Katowice, Poland, smolin@gig.katowice.pl,
Howaniec, N.
Central Mining Institute Department of Energy Saving and Air Protection Sq. Gwarkow 1 40-166 Katowice, Poland,
Unver-Somer, N.
Ege University Faculty of Pharmacy, Department of Pharmacognosy 35100 Bornova, Izmir Turkey,
Cicek-Polat, D.
Ege University Faculty of Pharmacy, Department of Pharmacognosy 35100 Bornova, Izmir Turkey,
Emir, A.
Ege University Faculty of Pharmacy, Department of Pharmacognosy 35100 Bornova, Izmir Turkey,
Onur, M. A.
Ege University Faculty of Pharmacy, Department of Pharmacognosy 35100 Bornova, Izmir Turkey,
Kaya, G. I.
Ege University Faculty of Pharmacy, Department of Pharmacognosy 35100 Bornova, Izmir Turkey,
Ahmed, A. B. A.
Bharathidasan University Department of Plant Science Tiruchirappalli 620 024 Tamil Nadu India, dr.bakrudeenaliahmed@yahoo.co.in,
Rao, A. S.
Bharathidasan University Department of Biotechnology Tiruchirappalli 620 024 Tamil Nadu India,
Rao, M. V.
Bharathidasan University Department of Plant Science Tiruchirappalli 620 024 Tamil Nadu India,
Taha, R. M.
University of Malaya Institute of Biological Sciences, Faculty of Science 50603 Kuala Lumpur Malaysia,
Choi, Y.
Sungkyunkwan University School of Pharmacy Suwon, Gyeonggi-do Korea,
Shin, B. S.
Catholic University of Daegu College of Pharmacy Gyeongsan-si, Gyeongbuk Korea,
Kim, M. G.
Sungkyunkwan University School of Pharmacy Suwon, Gyeonggi-do Korea,
Shin, S. W.
Sungkyunkwan University School of Pharmacy Suwon, Gyeonggi-do Korea,
Kim, T. H.
Catholic University of Daegu College of Pharmacy Gyeongsan-si, Gyeongbuk Korea,
Jang, H. C.
Sungkyunkwan University School of Pharmacy Suwon, Gyeonggi-do Korea,
Yoo, S. D.
Sungkyunkwan University School of Pharmacy Suwon, Gyeonggi-do Korea, sdyoo@skku.ac.kr,
Dong, S.
The 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 China, sqdong@licp.cas.cn,
Shi, X.
Gansu Academy of Medical Sciences Lanzhou 730000 China,
Liu, Q.
Graduate University of the Chinese Academy of Sciences Beijing 100039 China,
Zhang, Z.
The 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 China,
Zhao, L.
The 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 China,
Kumar, N.
IPDO Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad 500072 A.P India, navneetrajpoot21@yahoo.com,
Sangeetha, D.
.I.T. University Department of Chemistry, S.A.S. Vellore 632014 Tamilnadu India,
Goyal, R.
IPDO Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad 500072 A.P India,
Reddy, P. S.
IPDO Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad 500072 A.P India,
Abstract : A simple, selective, and stability-indicating reverse phase liquid chromatographic method has been developed and validated for the simultaneous determination of impurities and forced degradation products of quetiapine fumarate. The chromatographic separation was achieved on Inertsil-3 C8, 150 mm × 4.6 mm, 5 μm column at 35°C with UV detection at 217 nm using gradient mobile phase at a flow rate of 1.0 mL/min. Mobile phase A contains a mixture of 0.01 M di-potassium hydrogen orthophosphate (pH 6.8) and acetonitrile in the ratio of 80:20 (v/v), respectively, and mobile phase B contains a mixture of 0.01 M di-potassium hydrogen orthophosphate (pH 6.8) and acetonitrile in the ratio of 20:80 (v/v), respectively. The drug product was subjected to the stress conditions of oxidative, hydrolysis (acid and base), hydrolytic, thermal, and photolytic degradation. Quetiapine fumarate was found to degrade significantly in acid, base, and oxidative stress conditions. The degradation products were well resolved from main peak and its impurities. The mass balance was found to be in the range of 96.6–102.2% in all the stressed conditions, thus proved the stability-indicating power of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness.

Keywords : development, validation, forced degradation, stability-indicating, quetiapine fumarate, impurities,
Publishing house : University of Silesia in Katowice
Publication date : 2013
Number : Vol. 25, no. 2
Page : 393 – 409

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DOI :
Qute : Huo, H. L. ,Yu, S. H. ,Liu, X. Z. ,Meng, Y. ,Ren, Y. P. ,Zhang, L. T. ,Liu, L. ,Zhao, T. ,Cheng, X. M. ,Wang, C. H. ,Wang, Z. T. ,Gao, X. ,Jiang, X. ,Wang, L. ,Urban, J. ,Vaněk, J. ,Štys, D. ,Li, C. D. ,Liu, Y. ,Shi, Y. P. ,Zhang, Y. ,Peng, Q. ,Zeng, H. ,Yao, S. ,Zhang, Y. ,Song, H. ,Zhou, W. ,Zhang, X. Y. ,Lv, Y. P. ,Liu, X. D. ,Xu, C. ,Duan, G. L. ,Smoliński, A. ,Howaniec, N. ,Unver-Somer, N. ,Cicek-Polat, D. ,Emir, A. ,Onur, M. A. ,Kaya, G. I. ,Ahmed, A. B. A. ,Rao, A. S. ,Rao, M. V. ,Taha, R. M. ,Choi, Y. ,Shin, B. S. ,Kim, M. G. ,Shin, S. W. ,Kim, T. H. ,Jang, H. C. ,Yoo, S. D. ,Dong, S. ,Shi, X. ,Liu, Q. ,Zhang, Z. ,Zhao, L. ,Kumar, N. ,Sangeetha, D. ,Goyal, R. ,Reddy, P. S. ,Reddy, P. S. , A validated stability-indicating RP-LC method for the estimation of process-related impurities and degradation products of quetiapine fumarate in solid oral dosage form. Acta Chromatographica Vol. 25, no. 2/2013
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