Abstract

BOTET GARCIA, Martha et al. Validation of analytical method for quality control of B12 Vitamin-10 000 injection. Rev Cubana Farm [online]. 2009, vol.43, n.4, pp.53-60. ISSN 0034-7515.

Analytical method reported by USA Pharmacopeia was validated for quality control of injectable B₁₂ Vitamin (10 000 U) by UV spectrophotometry because this is a simpler and low-cost method allowing quality control of finished product. Calibration curve was graphed at 60 to 140 % interval, where it was linear with a correlation coefficient similar to 0, 9999; statistical test for interception and slope was considered non-significant. There was a recovery of 99.7 % in study concentrations interval where the Cochran (G) and Student(t) test were not significant too. Variation coefficient in repetition study was similar to 0.59 % for the 6 assayed replies, whereas in intermediate precision analysis, the Fisher and Student tests were not significant. Analytical method was linear, precise, specific and exact in study concentrations interval.

Keywords : UV spectrophotometry; cyanocobalamin; validation; injectable.

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