Pérez NM, Rodríguez HY, Suárez PY

Language: Spanish
References: 11
Page: 4-15
PDF size: 166.08 Kb.

ABSTRACT

Introduction: colchicine is a therapeutic alternative orally prescribed for acute gout. It is formulated as low dose tables due to its high toxicity. Dr A. Bjarner C.A laboratories manufacture Artrichine tablets and it requires a simple and reliable method to conduct quality control of the finished product that will consider ethanolsoluble characteristics, presence of chromophores and composition of colchicine formulation.
Objective: to validate an ultraviolet spectrophotometry-based method for the routine quality control.
Methods: a simple method by direct UV spectrophotometry which is modified from the set method of the British Pharmacopeia 2009 for tablets. It is based on the analyte extraction in absolute ethanol and the estimation at 350 nm. The method was validated on account of linearity, precision, accuracy and specificity against the formulation components.
Results: a very simple analytical methodology was established to obtain a transparent solution from the finished form, with the same concentration as that of the reference solution. The satisfactory compliance with all the acceptance criteria for the evaluated parameters allowed proving the validity of the study method for the quality control in the 50 to 150 % range (5-15 µg/ml).
Conclusions: the UV spectrophotometry-based method proved to be specific, linear, accurate and precise for the quality control of colchicine in Artrichine tablets.

REFERENCES

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