Comparison of FT-NIR and HPLC for Green Approach to Assay Cefixime in Its Pharmaceutical Capsules
 
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1
Sigma Pharmaceutical Industries, Quesna, Egypt
2
Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Egypt
Publish date: 2017-10-27
 
Eurasian J Anal Chem 2016;11(2):79–88
KEYWORDS
ABSTRACT
Near-infrared spectroscopy (NIRS) has become an analytical technique of great interest for the pharmaceutical industry, particularly as a greener analytical technique. In this paper a calibration model for cefixime in the capsules pharmaceutical dosage form was built by utilizing chemometric processing based mainly on a partial least square regression fit to assay the material using NIR technique. The results obtained by NIR spectroscopy were compared with the compendial HPLC method for cefixime capsules produced by USP. The present study showed that cefixime capsules can be individually analyzed by NIR with high accuracy. This proposed technique realizes a lot of green analytical aspects in developing eco-friendly analytical method.
 
REFERENCES (27)
1.
Haq, N., Iqbal, M., Alanazi, F. K., Alsarra, I. A., Shakeel, F. (2012). Applying green analytical chemistry for rapid analysis of drugs: Adding health to pharmaceutical industry, Arabian journal of chemistry. http://dx.doi.org/10.1016/j.ar....
 
2.
Bodson, C., Dew´e, W., Hubert, P. & Delattre, L. (2006). Comparison of FT-NIR transmission and UV–vis spectrophotometry to follow the mixing kinetics and to assay low-dose capsules containing riboflavin. Journal of Pharmaceutical and Biomedical Analysis 41, 783–790.
 
3.
PAT—A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, FDA, 2004 (http://fda.gov/cder).
 
4.
Ciurczak, E. W. & Drennen, J. K. (2002). Practical Spectroscopy Series: Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy, vol. 31, M. Dekker, New York, 192 pp.
 
5.
Plugge, W. & Van der Vlies, C. (1992). The Use of Near Infrared Spectroscopy in the Quality Control Laboratory of the Pharmaceutical Industry. J Pharm Biomed Anal, 10, 797–803.
 
6.
Gerh¨ausser, C. I., Kovar, K. A. (1997). Strategies for constructing near-infrared spectral libraries for the identification of drug substances. Appl. Spectrosc. 51, 1504–1510.
 
7.
Vredenbregt, M. J., Caspers, P. W. J., Hoogerbrugge, R. & Barends, D. M. (2003). Choice and validation of a NIR application for the identity control of starting materials: Practical experience with the eu draft note for guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data to be forwarded in Part II of the dossier for a marketing authorization. Eur J Pharm Biopharm, 56, 489–499.
 
8.
Sekulic, S. S., Ward, H. W. & Aldridge, P. K. (1996). On-line monitoring of powder blend homogeneity by near-in- frared spectroscopy. Anal Chem, 68, 509–513.
 
9.
Merckle, P. & Kovar, K. A. (1998). A novel method for analyzing thick tablets by near infrared spectroscopy. J Pharm Biomed Anal, 17, 365–374.
 
10.
Cogdill, R. P., Anderson, C. A. & Drennen, J. K. (2004). Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release. Pharm. Technol. 1, 29–34.
 
11.
El-Walily, A. F. M., Gazy, A. A., Belal, S. F. & Khamis, E. F. (2002). Quantitative determination of some thiazole cephalosporins through complexation with palladium (II) chloride. J Pharm Biomed Anal, 22, 385–392. http://dx.doi.org/10.1016/S073... 7085(99)00281-2. [PubMed].
 
12.
Saleh, G. A., Askal, H. F., Darwish, I. A. & El-Shorbagi, A. A. (2003). Spectroscopic analytical study for the charge-transfer complexation of certain cephalosporins with chloranilic acid. Anal Sci, 19, 281–287. http://dx.doi.org/10.2116/anal.... [PubMed].
 
13.
Bebawy, L. I., El-Kelani, K. & Fattah, L. A. (2003). Fluorimetric determination of some antibiotics in raw material and dosage forms through ternary complex formation with terbium (Tb3+). J. Pharm. Biomed. Anal. 32, 1219–1225. http://dx.doi.org/10.1016/ S0731-7085(03)00161-4. [PubMed].
 
14.
Golcu, A., Dogan, B. & Ozkan, S. A. (2005). Anodic voltammetric behavior and determination of cefixime in pharmaceutical dosage forms and biological fluids. Talanta 67, 703–712. http://dx.doi.org/10.1016/j.ta.... [PubMed].
 
15.
Jain, R., Gupta, V. K., Jadon, N. & Radhapyari, K. (2010). Voltammetric determination of cefixime in pharmaceuticals and biological fluids. Anal Biochem, 407, 79–88. http://dx.doi.org/ 10.1016/j.ab.2010.07.027. [PubMed].
 
16.
Manna, L, & Valvo, L. (2004). Development and Validation of a Fast Reversed-Phase IonPairing Liquid Chromatographic Method for Simultaneous Determination of Eight Cephalosporin Antibiotics in Pharmaceutical Formulations. Chromatographia. 60, 645– 649. http://dx.doi.org/10.1365/s103....
 
17.
Meng, F., Chen, X., Zeng, Y. & Zhong, D. (2005). Sensitive liquid chromatography–tandem mass spectrometry method for the determination of cefixime in human plasma: Application to a pharmacokinetic study. J. Chromatogr. B, 819, 277–282. http://dx.doi.org/10.1016/j.jc.... [PubMed].
 
18.
Gonzalez-Hernandez, R., Nuevas-Paz, L., Soto-Mulet, L., Lopez-Lopez, M. & Hoogmartens, J. (2001). Reversed phase high performance liquid chromatographic determination of cefixime in bulk drugs. J. Liq. Chromatogr. Relat. Technol. 24, 2315– 2324. http://dx.doi.org/10.1081/JLC-....
 
19.
Singh, D. K. & Maheshwari, G. (2010). Chromatographic studies of some cephalosporins on thin layers of silica gel G–zinc ferrocyanide. Biomed. Chromatogr. 24, 1084–1088. http://dx.doi.org/10.1002/bmc..... [PubMed].
 
20.
Khandagle, K. S., Ganddhi, S. V., Deshpande, P. B. & Gaikwad, N. V. (2011). A simple and sensitive RPHPLC method for simultaneous estimation of cefixime and ofloxacin in combined tablet dosage form. Int. J. Pharm. Pharm. Sci. 3, 46–48.
 
21.
Eric-Jovanovic, S., Agbaba, D., Zivanov-Stakic, D. & Vladimirov, S. (1998). HPTLC determination of ceftriaxone, cefixime and cefotaxime in dosage forms. J. Pharm. Biomed. Anal. 18, 893–898. http://dx.doi.org/10.1016/S073.... [PubMed].
 
22.
Barnes, R. J., Dhanoa, M. S. & Lister, S. J. (1989). Standard Normal Variate Transformation and De-trending of Near- Infrared Diffuse Reflectance Spectra. Applied Spectroscopy, 43 (5), 772-777. doi:10.1366/0003702894202201.
 
23.
Martens, H. & Stark, E. (1991). Extended multiplicative signal correction and spectral interference subtraction: new preprocessing methods for near infrared spectroscopy. Journal of Pharmaceutical and Biomedical Analysis, 9(89, 625–635.
 
24.
The United States Pharmacopoeia (2013) Monograph of cefixime, 36th edition, United States Pharmacopoeial Convention, Rockville.
 
25.
ICH Q2B, (2002) International Conference on Harmonisation, Validation of analytical procedures. Methodology,.
 
26.
International Conference on Harmonisation Topic Q2B (2002) Validation of Analytical Methods: Methodology. The Third International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Yokohama-japan.
 
27.
Eustaquio, A., Graham, P., Jee, R. D., Moffat, A. C., Trafford, A. D. (1998). Basic principles of NIR. Analyst, 123, 2303–2306.
 
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