AJAC  Vol.6 No.9 , August 2015
Evaluation Procedure for Quality Consistency of Generic Nifedipine Extended-Release Tablets Based on the Impurity Profile
Abstract: A procedure to evaluate the quality consistency of generic drugs based on the impurity profile and the similarity analysis methods was presented in this paper. Nifedipine extended-release tablets from six generic factories of China were used to evaluate the uniformity with the original drug in the study. The procedure includes: choice of chromatographic methods, data collection and conformity test, evaluation of intra-batch similarity of drugs, evaluation of generic drugs with the original drug and weighted similarity evaluation of generic drugs. The data were collected via high-performance liquid chromatography (HPLC), and then calculated by correlation coefficient, cosine, principal component analysis (PCA) and hierarchical clustering analysis (HCA). It is more suitable to use peak areas as the vector when calculating the similarity of impurity profile. After weighting the peak areas of the unspecified impurities in further evaluation of the generic quality, the generic level of different factories was differentiated and the best generic factory was picked out.
Cite this paper: Zhang, M. , Zhang, J. , Gao, Q. , Liu, Y. and Lu, F. (2015) Evaluation Procedure for Quality Consistency of Generic Nifedipine Extended-Release Tablets Based on the Impurity Profile. American Journal of Analytical Chemistry, 6, 776-785. doi: 10.4236/ajac.2015.69074.

[1]   Schneider, A. and Wessjohann, L. (2010) Comparison of Impurity Profiles of Orlistat Pharmaceutical Products Using HPLC Tandem Mass Spectrometry. Journal of Pharmaceutical and Biomedical Analysis, 53, 767-772.

[2]   Byrn, S.R., Tishmack, P.A., Milton, M.J. and van de Velde, H. (2011) Analysis of Two Commercially Available Bortezomib Products: Differences in Assay of Active Agent and Impurity Profile. AAPS PharmSciTech, 12, 461-467.

[3]   Mayeno, A.N., Lin, F., Foote, C.S., Loegering, D.A., Ames, M.M., Hedberg, C.W. and Gleich, G.J. (1990) Characterization of “Peak E”, a Novel Amino Acid Associated with Eosinophilia-Myalgia Syndrome. Science, 250, 1707-1708.

[4]   Wienen, F., Deubner, R. and Holzgrabe, U. (2003) Composition and Impurity Profile of Multisource Raw Material of Gentamicin—A Comparison. Pharmeuropa, 15, 273-279.

[5]   Holzgrabe, U., Deubner, R. and Wienen, F. (2004) Quality of APIs Result of a Research of Different Gentamicin Products. Am Pharm Outsourc, 5, 24-28.

[6]   Gorog, S. (2006) The Importance and the Challenges of Impurity Profiling in Modern Pharmaceutical Analysis. TrAC Trends in Analytical Chemistry, 25, 755-757.

[7]   Guideline IHT (2002) Impurities in New Drug Products. Q3B (R1), Current Step, 4.

[8]   Dumarey, M., van Nederkassel, A., Stanimirova, I., Daszykowski, M., Bensaid, F., Lees, M., Martin, G., Desmurs, J., Smeyers-Verbeke, J. and Vander Heyden, Y. (2009) Recognizing Paracetamol Formulations with the Same Synthesis Pathway Based on Their Trace-Enriched Chromatographic Impurity Profiles. Analytica Chimica Acta, 655, 43-51.

[9]   Lee, J.S., Chung, H.S., Kuwayama, K., Inoue, H., Lee, M.Y. and Park, J.H. (2008) Determination of Impurities in Illicit Methamphetamine Seized in Korea and Japan. Analytica Chimica Acta, 619, 20-25.

[10]   Dayrit, F.M. and Dumlao, M.C. (2004) Impurity Profiling of Methamphetamine Hydrochloride Drugs Seized in the Philippines. Forensic Science International, 144, 29-36.

[11]   Mitrevski, B., Veleska, B., Engel, E., Wynne, P., Song, S.M. and Marriott, P.J. (2011) Chemical Signature of Ecstasy Volatiles by Comprehensive Two-Dimensional Gas Chromatography. Forensic Science International, 209, 11-20.

[12]   Fraga, C.G., Farmer, O.T. and Carman, A.J. (2011) Anionic Forensic Signatures for Sample Matching of Potassium Cyanide Using High Performance Ion Chromatography and Chemometrics. Talanta, 83, 1166-1172.

[13]   Gan, F. and Ye, R. (2006) New Approach on Similarity Analysis of Chromatographic Fingerprint of Herbal Medicine. Journal of Chromatography A, 1104, 100-105.

[14]   Liang, P.R. and Peng, G. (2000) Hyperspectral Remote Sensing and Its Applications. Beijing Higher Education Press, Beijing.

[15]   Zhang, Z.-M., Chen, S. and Liang, Y.-Z. (2010) Baseline Correction Using Adaptive Iteratively Reweighted Penalized Least Squares. Analyst, 135, 1138-1146.

[16]   Vest Nielsen, N.-P., Carstensen, J.M. and Smedsgaard, J. (1998) Aligning of Single and Multiple Wavelength Chromatographic Profiles for Chemometric Data Analysis Using Correlation Optimised Warping. Journal of Chromatography A, 805, 17-35.

[17]   Tomasi, G., van den Berg, F. and Andersson, C. (2004) Correlation Optimized Warping and Dynamic Time Warping as Preprocessing Methods for Chromatographic Data. Journal of Chemometrics, 18, 231-241.

[18]   Sharaf Dli, M.A. and Kowalski, B.R. (1986) Chemometrics. John Wiley & Sons, New York.

[19]   Daszykowski, M., Walczak, B. and Massart, D.L. (2003) Chemometr. Chemometrics and Intelligent Laboratory Systems, 65, 97-112.

[20]   Massart, D.L. and Kaufman, L. (1983) The Interpretation of Analytical Chemical Data by the Use of Cluster Analysis. John Wiley & Sons, New York.

[21]   Vandeginste, B., Massart, D., Buydens, L., De Jong, S., Lewi, P. and Smeyers-Verbeke, J. (1983) Handbook of Chemometrics and Qualimetrics: Part B. Elsevier, Amsterdam, 69.

[22]   The United States Pharmacopeial Convention (2011) 2011 USP 34 NF 29 3-Volume Set. The United States Pharmacopeial Convention Inc., Rockville, 3659.

[23]   (WS1-(X-058)-2004Z) NDS (2004) China’s State Food and Drug Administration. 124-125.

[24]   Prakash, B.D. and Wei, Y.C. (2011) A Fully Automated Iterative Moving Averaging (AIMA) Technique for Baseline Correction. Analyst, 136, 3130-3135.