Development and application of stability-indicating HPLC method for the determination of nevirapine and its impurity in combination drug product

Czasopismo : Acta Chromatographica
Tytuł artykułu : Development and application of stability-indicating HPLC method for the determination of nevirapine and its impurity in combination drug product

Autorzy :
Xu, L. N.
Yantai University Department of Applied Chemistry Yantai 264005 P.R. China,
Gai, F. Y.
Yantai University Department of Applied Chemistry Yantai 264005 P.R. China,
Mu, G. F.
Yantai University Department of Applied Chemistry Yantai 264005 P.R. China,
Gao, Y.
Yantai University Department of Applied Chemistry Yantai 264005 P.R. China,
Liu, C. J.
Yantai University Department of Applied Chemistry Yantai 264005 P.R. China,
Luan, F.
Yantai University Department of Applied Chemistry Yantai 264005 P.R. China,
Mori, M.
Gunma University Department of Chemistry and Chemical Biology, Graduate School of Engineering 1-5-1 Tenjin-cho Kiryu 376-8515 Japan,
Ikeda, T.
Gunma University Department of Chemistry and Chemical Biology, Graduate School of Engineering 1-5-1 Tenjin-cho Kiryu 376-8515 Japan,
Itabashi, H.
Gunma University Department of Chemistry and Chemical Biology, Graduate School of Engineering 1-5-1 Tenjin-cho Kiryu 376-8515 Japan,
Soomro, R.
University of Sindh National Center of Excellence in Analytical Chemistry Jamshoro Pakistan,
Memon, S. Q.
University of Sindh Institute of Advance Research in Chemical Sciences Jamshoro Pakistan,
Ahmed, M. J.
University of Chittagong Laboratory of Analytical Chemistry, Department of Chemistry Chittagong 4331 Bangladesh,
Memon, N.
University of Sindh National Center of Excellence in Analytical Chemistry Jamshoro Pakistan, najmamemon@gmail.com,
Mallah, A.
University of Sindh M.A. Kazi Institute of Chemistry Jamshoro Pakistan,
Ravi, P. R.
BITS-Pilani Hyderabad Campus Pharmacy Department Ranga Reddy (Dist.) Jawaharnagar Andhra Pradesh India, rahulvats1983@gmail.com,
Aditya, N.
BITS-Pilani Hyderabad Campus Pharmacy Department Ranga Reddy (Dist.) Jawaharnagar Andhra Pradesh India, adityamurthy1212@gmail.com,
Vats, R.
BITS-Pilani Hyderabad Campus Pharmacy Department Ranga Reddy (Dist.) Jawaharnagar Andhra Pradesh India, rpunnarao@gmail.com,
Navaneethan, G.
Sona College of Technology (Anna University) Department of Sciences Salem 636 005 India,
Karunakaran, K.
Sona College of Technology (Anna University) Department of Sciences Salem 636 005 India, drkk@sonatech.ac.in,
Elango, K. P.
Gandhigram Rural Institute (Deemed University) Department of Chemistry Gandhigram 624 302 India,
Abstrakty : A stability-indicating reversed-phase high-performance liquid chromatography method has been developed and validated for the estimation of nevirapine and its impurity, namely the related compound A and the related compound B in combination drug product. The separation was carried out on SUPELCOSIL ABZ (150 mm × 4.6 mm, 5 µm) column. Tablet was admitted to the stress conditions of acid, base, peroxide, thermal, humidity, and photolytic degradation. The degradation products were well resolved from nevirapine, and its impurities peaks and the peak homogeneity of compound were obtained using photo diode array detector, hence proving the stability-indicating nature of the method. Moreover, to prove the selectivity of the method, individual lamivudine, zidovudine, and their main impurities were injected. The developed method was linear for nevirapine from 120 to 360 µg mL-1, and the linear regression obtained was >0.999. Recovery data were in the range 98.2–101.5%. The limit of quantification for related compound A and related compound B was found to be 0.02%. The proposed method was validated according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines and proved suitable for stability testing and quality control of these drugs in pharmaceutical preparations.

Słowa kluczowe : assay, related substances, stability indicating, nevirapine, HPLC,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2012
Numer : Vol. 24, no. 4
Strony : 575 – 587
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DOI :
Cytuj : Xu, L. N. ,Gai, F. Y. ,Mu, G. F. ,Gao, Y. ,Liu, C. J. ,Luan, F. ,Mori, M. ,Ikeda, T. ,Itabashi, H. ,Soomro, R. ,Memon, S. Q. ,Ahmed, M. J. ,Memon, N. ,Mallah, A. ,Ravi, P. R. ,Aditya, N. ,Vats, R. ,Navaneethan, G. ,Karunakaran, K. ,Elango, K. P. , Development and application of stability-indicating HPLC method for the determination of nevirapine and its impurity in combination drug product. Acta Chromatographica Vol. 24, no. 4/2012
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