Analytical Method Development and Validation for Determination of Residual Solvent in Zopiclone Tablets by Headspace Gas Chromatography
 
More details
Hide details
1
Cipla Ltd., INDIA
Online publish date: 2016-12-07
Publish date: 2016-12-07
 
Eurasian J Anal Chem 2017;12(1):95–103
KEYWORDS:
TOPICS:
ABSTRACT:
A simple and sensitive headspace gas chromatographic method has been developed and validated for simultaneous determination of isopropyl alcohol and methylene chloride in zopiclone tablets. The separation was achieved on 75 m long DB-624 fused silica column, 0.53 mm inner diameter and 3 μ film thickness using nitrogen as a carrier gas at 6 ml/min flow and FID as a detector. The developed gas chromatographic method offers symmetric peak shape, good resolution and reasonable retention time for all the solvents. The limit of detection of isopropyl alcohol and methylene chloride was found to be 250 μg/tablet and 90 μg/tablet, respectively.
CORRESPONDING AUTHOR:
Chetan M Bhalgat   
Analytical R&D (API-IPD), Cipla Ltd, Vikhroli (W), Mumbai-400083, Maharashtra, India
 
REFERENCES (22):
1. International Conference on Harmonisation Guideline for Residual Solvents. (1997). Q3C (R3).
2. United State Pharmacopeia 35. (2010). United States Pharmacopieal Convention Inc. Rockville, MD, USA.
3. European Pharmacopeia 7.0. (2010). Concil of Europe, Strasbourg, France.
4. Japnese Pharmacopoeia (16th ed). (2011). Society of Japanese pharmacopoeia, Tokyo.
5. Grodowska, K., & Parczewski, A. (2010). Organic solvents in the pharmaceutical industry. Acta Poloniae Pharmaceutica-Drug Research, 67, 3–12.
6. Gaillard, Y., Gay-Montchamp, J., & Ollagnier, M. (1993). Gas chromatographic determination of zopiclone in plasma after solid-phase extraction. Journal of Chromatography B, Biomedical Sciences and Applications, 619, 310–314.
7. Bouklouze, A. A., Viré, J. C., Quarin, G. C., & Kauffmann, J. M. (1994). Quantitative analysis of zopiclone in tablets using ion-selective electrode and polarographic methods. Electroanalysis, 6, 1045–1050.
8. Squella, J. A., Sturm, J. C., Alvarezlueje, A., & Nunezvergara, L. J. (1994). Voltametric behavior of zopiclone - polarographic determination in tablets. Journal of AOAC International, 77, 768–773.
9. Paw, B., & Misztal, G. (2000). Determination of zopiclone in tablets by HPLC and UV-spectrophotometry. Journal of Pharmaceutical and Biomedical Analysis, 23, 819–823.
10. Bounine, J. P., Tardif, B., Beltran, P., & Mazzo, D. J. (1994) High-performance liquid chromatographic stability-indicating determination of zopiclone in tablets. Journal of Chromatography A, 677, 87–93.
11. The British Pharmacopoeia. (2012). Her Majestry’s Stationary office, London, (electronic Version).
12. Van Bocxlaer, J., Meyer, E., Clauwaert, K., Lambert, W., Piette, M., & De Leenheer, A. (1996). Analysis of zopiclone (Imovane®) in postmortem specimens by GC-MS and HPLC with diode-array detection. Journal of Analytical Toxicology, 20, 52–54.
13. Kataev, S. S., Zelenina, N. B., Khomov, Y. A., Koksharova, N. V., & Daiekh, M. (2007). Determination of zopiclone in urine by gas chromatography-mass spectrometry. Journal Analytical Chemistry, 62, 458–462.
14. Rohrig, T. P., Norton, M. C., & Harryman, L. A. (2010). Identification and quantitation of zopiclone in biological matrices using gas chromatography-mass spectrometry (GC-MS). Methods in Molecular Biology, 603, 527–533.
15. Pushpalatha, P., Sarin, R. K., Rao, M. A., & Baggi, T. R. (2009). A new thin-layer chromatographic method for analysis of zolpidem and zopiclone. Journal of Planar Chromatography, 22, 449–451.
16. Bouklouze, A., Viré, J. C., Quarin, G. C., & Kauffmann, J. M. (1994). Quantitative analysis of zopiclone in tablets using ion-selective electrode and polarographic methods. Electroanalysis, 6, 1045–1050.
17. Viré, J. C., Zhang, H., Quarin, G., Patriarche, G. J., Sentürk, Z., & Christian, G. D. (1993). Electrochemical behavior of zopiclone. Talanta, 40, 313–323.
18. Yılmaz, S. (2009). Adsorptive stripping voltammetric determination of zopiclone in tablet dosage forms and human urine. Colloids and Surfaces B, Biointerfaces, 71, 79–83.
19. Sangaraju, S., Lakshmi Kanth, M., Rao, B. M., & Someswararao, N. (2009). Enantiomeric separation of S-zopiclone and its R-enantiomer in bulk drug samples by validated chiral RP-HPLC. Die Pharmazie – International Journal of Pharmaceutical Sciences, 64, 717–719.
20. Bounine, J., Tardif, B., Beltran, P., & Mazzo, D. J. (1994). High-performance liquid chromatographic stability-indicating determination of zopiclone in tablets. J. Chromatogr. A, 677, 87–93.
21. Abdelrahman, M. M., Naguib, I. A., El Ghobashy, M. R., & Ali, N. A. (2015). Quantitative determination of zopiclone and its impurity by four different spectrophotometric methods. Spectrochimica Acta Part A, Molecular and Biomolecular Spectroscopy, 137, 617–624.
22. International Conference on Harmonization Guideline on Validation of Analytical Procedures, Text and Methodology. (2005).` Q2 (R1).
eISSN:1306-3057