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.