Determination of the Stability Studies of the Sudanese Camel Insulin


The main objective of the presented study was to characterize the stability of the Sudanese camel insulin after 6 months of its extraction, purification and formulation from the fresh pancreatic glands of the camel, slaughtered for local and export consumption. The stability and purity of the formulated insulin samples were compared to standard insulin sam-ples that of the leading manufacturing companies using some analytical techniques such as HPLC, gel electrophoresis and atomic absorption. In another part of the study, the direct transfer method was used to accomplish sterility test by complete immersion of the insulin samples into thioglycollate and soybean medium. The data were presented as mean ± S.E.M (standard error of means) for the comparison of zinc (mg/units) and nitrogen (in percentage) concentrations in standard and testing camel insulin samples, respectively. Similarly, the linear equation was derived and the coefficient factors for standard and testing insulin samples were compared to determine the peak area and the concentrations of the camel insulin samples (mean ± S.E.M) after HPLC elution. The P value, P < 0.005, was considered statistically signifi-cant. The stability study tests of the insulin samples (zinc and nitrogen contents, sterility, purity and potency test) reflect clearly their equivalence to standard insulin formulations in terms of stability. The results revealed that the stability of the various insulin samples from the camel insulin is not less than 25% of the time remaining until the preparations ex-pire or six months earlier than the expiration date when compared to standard insulin samples.

Share and Cite:

A. Baragob, W. AlMalki, I. Shahid, H. Bafhaid, F. Bakhdhar, S. Khojali and S. Abdella, "Determination of the Stability Studies of the Sudanese Camel Insulin," Pharmacology & Pharmacy, Vol. 4 No. 7, 2013, pp. 549-555. doi: 10.4236/pp.2013.47079.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] L. H. Brown, K. Krumperman and C. J. Fullagar, “Out-of-Hospital Medication Storage Temperatures: A Review of the Literature and Directions for the Future,” Prehospital Emergency Care, Vol. 8, No. 2, 2004, pp. 200-206.
[2] M. M. Grajower, C. G. Fraser, J. H. Holcombe, M. L. Daugherty, W. C. Harris and M. R. De Felippis, “How Long Should Insulin Be Used Once a Vial Is Started,” Diabetes Care, Vol. 26, No. 9, 2003, pp. 2665-2669.
[3] P. S. Adams, R. F. Haines-Nutt and R. Town, “Stability of Insulin Mixtures in Disposable Plastic Insulin Syringes,” The Journal of Pharmacy and Pharmacology, Vol. 39, No. 6, 1987, pp. 158-163.
[4] C. Chandler, C. M. Gryniewicz, T. Pringle and F. Cunningham, “Insulin Temperature and Stability under Stimulated Transit Conditions,” American Journal of HealthSystem and Pharmacology, Vol. 65, No. 10, 2008, pp. 953-963.
[5] M. Pingel and A. Volund, “Stability of Insulin Preparations,” Diabetes, Vol. 21, No. 7, 1972, pp. 805-813.
[6] United States Pharmacopoeia Convention, “Parenteral, Preparation; Soluble Insulin, Insulin Zinc Suspension Crystalline, Insulin Zinc Suspension Amorphous, Insulin Zinc Suspension Mixed,” United States Pharmacopoeia, 2000, pp. 807-808.
[7] S. Melville, M. Goodell and N. Arthur, “Factors Influencing the Stability of Insulin,” Journal of Biological Chemistry, Vol. 117, No. 2, 1937, pp. 685-691.
[8] British Pharmacopoeia, “Determination of Zinc Content by Atomic Absorption. The Method of Direct Calibration,” Vol. 2, Appendix VIII, 2000, pp. 124-125.
[9] British Pharmacopoeia, “Determination of Nitrogen Content by Titration Method,” Vol. 2, 2000, Appendix VIII, pp. 104-105.
[10] Sebia Instruction, “Test for Purity of Insulin Using Electrophoresis,” 2003.
[11] United State pharmacopoeia Convention, “Sterility Test, Direct Transfer Method,” United State pharmacopoeia, 2000, pp. 822-824.
[12] A. Oliva, J. Farina and M. Llabrés, “Development of Two High-Performance Liquid Chromatography Methods for the Analysis and Characterization of Insulin and Its Degradation Products in Pharmaceutical Preparations,” British Journal of Biomedical Sciences and Chromatography, Vol.749, No. 1, 2000, pp. 25-34.
[13] R. Gregory, S. Edwards and N. A. Yateman, “Demonstration of Insulin Transformation Products in Insulin Vials by High-Performance Liquid Chromatography,” Diabetes Care, Vol. 14, No. 1, 1991, pp. 42-48.

Copyright © 2023 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.