Implementation of design of experiments for optimization of forced degradation conditions and development of a stability-indicating method for furosemide.

作者: Moolchand Kurmi , Sanjay Kumar , Bhupinder Singh , Saranjit Singh

DOI: 10.1016/J.JPBA.2014.03.035

关键词:

摘要: The study involved optimization of forced degradation conditions and development a stability-indicating method (SIM) for furosemide employing the design experiment (DoE) concept. conditions, especially hydrolytic oxidative, was done by application 2(n) full factorial designs, which helped to obtain targeted 20-30% drug also enriched levels products (DPs). For selective separation its DPs SIM, DoE applied in three different stages, i.e., primary parameter selection, secondary screening optimization. these three, IV-optimal, Taguchi orthogonal array face-centred central composite designs were employed, respectively. organic modifier, buffer pH, gradient time initial hold selected as parameters. Initial final modifier percentage, flow rate came out critical parameters during screening, further evaluated Based on results, an optimized obtained wherein total twelve separated successfully. exposed behaviour conditions.

参考文章(22)
Ling-Jen Chen, Leo T. Burka, Chemical and enzymatic oxidation of furosemide: formation of pyridinium salts. Chemical Research in Toxicology. ,vol. 20, pp. 1741- 1744 ,(2007) , 10.1021/TX700262Z
R. Nagendra, Roopa S. Pai, Gurinder Singh, Stability of furosemide and aminophylline in parenteral solutions Brazilian Journal of Pharmaceutical Sciences. ,vol. 47, pp. 89- 96 ,(2014) , 10.1590/S1984-82502011000100011
J.H.McB. Miller, J.L. Robert, A.M. Sørensen, Reversed-phase ion-pair liquid chromatographic method for determining the impurities of furosemide. Journal of Pharmaceutical and Biomedical Analysis. ,vol. 11, pp. 257- 261 ,(1993) , 10.1016/0731-7085(93)80206-G
Hans Bundgaard, Tina Nørgaard, Niels Mørk Nielsen, Photodegradation and hydrolysis of furosemide and furosemide esters in aqueous solutions International Journal of Pharmaceutics. ,vol. 42, pp. 217- 224 ,(1988) , 10.1016/0378-5173(88)90178-0
Saranjit Singh, Mahendra Junwal, Gajanan Modhe, Harsita Tiwari, Moolchand Kurmi, Neha Parashar, Padmaja Sidduri, Forced degradation studies to assess the stability of drugs and products Trends in Analytical Chemistry. ,vol. 49, pp. 71- 88 ,(2013) , 10.1016/J.TRAC.2013.05.006
C. Hubert, P. Lebrun, S. Houari, E. Ziemons, E. Rozet, Ph. Hubert, Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process. Journal of Pharmaceutical and Biomedical Analysis. ,vol. 88, pp. 401- 409 ,(2014) , 10.1016/J.JPBA.2013.09.026
Sandeep Sonawane, Paraag Gide, AN EXPERIMENTAL DESIGN APPROACH FOR THE FORCED DEGRADATION STUDIES AND DEVELOPMENT OF A STABILITY-INDICATING LC METHOD FOR EPLERENONE IN TABLETS Journal of Liquid Chromatography & Related Technologies. ,vol. 34, pp. 2020- 2031 ,(2011) , 10.1080/10826076.2011.582913
Gy. Székely, B. Henriques, M. Gil, A. Ramos, C. Alvarez, Design of experiments as a tool for LC–MS/MS method development for the trace analysis of the potentially genotoxic 4-dimethylaminopyridine impurity in glucocorticoids Journal of Pharmaceutical and Biomedical Analysis. ,vol. 70, pp. 251- 258 ,(2012) , 10.1016/J.JPBA.2012.07.006