Rajeev Kumar R. Singh, Manapragada V. Rathnam, Sangeeta J. Singh, Raju V. K. Vegesna

Abstract: This research paper describes simple analytical method for determination of Camylofin dihydrochloride and Nimesulide in tablet formulation by Gas chromatography method. Benzoic acid was used as internal standard. Validation was carried out in compliance with the International Conference on Harmonization guidelines. The method utilized GC (Agilent Technologies 6890 N Network GC system with FID detector), and RTX-5 capillary column (5% diphenyl-95% dimethyl polysiloxane), 30 m × 0.53 mm, 1.5 µm as stationary phase. Helium was used as the carrier gas at a flow rate of 1.5 mL?min–1. The proposed method was validated for linearity, LOD, LOQ, accuracy, precision, ruggedness and solution stability. It can be conveniently adopted for routine quality control analysis.

Keywords: Capillary Column, Gas Chromatography, Pharmaceutical Preparations, Camylofin Dihydrochloride, Nimesulide

Cite this paper: nullR. Singh, M. Rathnam, S. Singh and R. Vegesna, "Determination of Camylofin Dihydrochloride and Nimesulide in Pharmaceutical Preparation by Gas Chromatography," American Journal of Analytical Chemistry, Vol. 2 No. 8, 2011, pp. 944-952. doi: 10.4236/ajac.2011.28110.

References

[1]   Sweetman and S. C. Martindale, “The Complete Drug Reference,” 36th Edition, 2009.

[2]   M. J. Oneil, A. Smith and P. E. Heckelman, “The Merck Index,” 13th Edition, Merck & Co. Inc, White House Station, 2001.

[3]   G. Khaksa and N. Udupa, “Rapid and Sensitive Method for Determination of Nimesulide in Human Plasma by High-Performance Liquid Chromatography,” Journal of Chromatography B: Biomedical Sciences and Applications, Vol. 727, No. 1-2, 1999, pp. 241-244. doi:10.1016/S0378-4347(98)00567-2

[4]   D. J. Jaworowicz, M. T. Filipowski and K. M. K. Boje, “Improved High Performance Liquid Chromatographic Assay for Nimesulide,” Journal of Chromatography B, Vol. 723, 1999, pp. 293-299. doi:10.1016/S0378-4347(98)00559-3

[5]   S. S. Zarapkar, N. P. Bhandari and U. P. Halkar, “Simultaneous Determination of Nimesulide and Chlorzoxazone in Pharmaceutical Dosage by RP HPLC,” Indian Drugs, Vol. 37, 2000, p. 467.

[6]   B. Raman and D. Patil, “RPHPLC for the Simultaneous Estimation of Tinidazole and Nimesulide in Tablets,” Indian Drugs, Vol. 39, 2002, pp. 392-394.

[7]   P. Kovaikova, M. Mokry and J. Klime, “Photochemical Stability of Nimesulide,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 31, No. 4, 2003, pp. 827-832. doi:10.1016/S0731-7085(02)00659-3

[8]   B. S. Nagaralli, J. G. Seetharamappa, B. G. Gowda and M. B. Melwanki, “High Performance Liquid Chromatography Method for the Determination of Nimesulide in Pharmaceutical Preparations,” Journal of Analytical Chemistry, Vol. 58, No. 8, 2003, pp. 873-875. doi:10.1023/A:1025095829622

[9]   R. Nageswara Rao , S. Meena , D. Nagaraju , A. Raghu Ram Rao, “Development and Validation of a Reversed- phase Liquid Chromatographic Method for Separation and Simultaneous Determination of COX-2 Inhibitors in Pharmaceuticals and Its Application to Biological Fluids,” Biomedical Chromatography, Vol. 19, No. 5, 2004, pp. 362-368. doi:10.1002/bmc.458

[10]   P. D. Tzanavaras and D. G. Themelis, “Validated High-Throughput HPLC Assay for Nimesulide Using a Short Monolithic Column,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 43, No. 4, 2006, pp. 1483- 1487. doi:10.1016/j.jpba.2006.10.014

[11]   H. Nimje, S. P. Wate and D. P. Dharkar, “Determination of Nimesulide and Tizanidine in Tablets,” Indian Journal of Pharmaceutical Sciences, Vol. 69, No. 2, 2007, pp. 281-283. doi:10.4103/0250-474X.33158

[12]   M. Mokry, J. Klimes and J. Pechova, “HPLC Analysis of a Syrup Containing Nimesulide and Its Hydrolytic Degradation Product,” Chemical Papers, Vol. 64, 2010, pp. 405-408. doi:10.2478/s11696-010-0001-2

[13]   F. A. Elbarbry, M. M. Mabrouk and M. A. El-Dway, “Determination of the Analgesic Components of Spasmomigraine Tablet by Liquid Chromatography with Ultraviolet Detection,” Journal of AOAC International, Vol. 90, No. 1, 2007, pp. 94-101.

[14]   P. S. Barde, A. Y. Desai, S. M. N. Roy and V. V. Vaidya, “Simultaneous RP HPLC Determination of Camylofin Dihydrochloride in Pharmaceutical Preparation,” TSI Journal, Vol. 7, No. 10, 2008.

[15]   R. R. Singh, M. V. Rathnam and R. Vegesna, “Simultaneous RP HPLC Determination of Camylofin Dihydrochloride and Paracetamol in Pharmaceutical Preparations,” TSI Journal, Vol. 7, No. 11, 2008.

[16]   M. V. Rathnam and R. R. Singh, “Simultaneous RP HPLC Determination of Camylofin Dihydrochloride and Diclofenac Potassium in Pharmaceutical Preparations,” Pharm Anal Acta, Vol. 1, No. 2, 2010, p. 1000108. doi:10.4172/2153-2435.1000108

[17]   E. Crombeza, W. Van Den Bosschea and P. De Moerloosea, “Gas Chromatographic Determination of Camylofine Dihydrochloride in Tablets and Suppositories,” Journal of Chromatography A, Vol. 117, No. 1, 1976, pp 161-166. doi:10.1016/S0021-9673(00)81077-8

[18]   L. R. Snyder, J. J. Kirland and J. L. Glajch, “Practical HPLC Method Development,” 2nd Edition, John Wiley and sons, Inc., Hokoben, 1997.

[19]   ICH, “Validation of Analytical Procedures; Text and Methodology,” International Conference on Harmonization Guidance Documents, Q2 (R1), 2005.

[20]   ICH, “Photo Stability Testing of New Drugs Substances and Products,” International Conference on Harmonization Guidance Documents, Q1B, 2005.

[21]   ICH, “Stability Testing of New Drug Substances and Products,” International Conference on Harmonization Guidance Documents, Q1A (R20), 2005.