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2016, Number 1

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Rev Cubana Farm 2016; 50 (1)

Evaluation of the performance of the analytical methods applied to Cuban-made 100 mg retard sodium diclofenac

García PCM, García BL, Robaina MM, Fariñas SOC, Díaz PI, Cataño FJL

Language: Spanish
References: 17
Page: 16-29
PDF size: 188.04 Kb.


ABSTRACT

Introduction: sodium dicloflenac is a phenylacetic acid derivate included in the non-steroidal anti-inflammatory group, with marked analgesic and antipyretic properties. The US Pharmacopeia (USP 36, 2013) reports the analytical methods for the quality control of sodium diclofenac in the active ingredient and in tablets.
Objectives: to evaluate the performance of the analytical methods used in the quality control of quantitation and the stability studies of the active ingredient as well as the dissolution tests of the Cuban-made 100 mg retard sodium diclofenac.
Methods: the evaluation of the performance of the potentiometric analytical method for quantitation of the active ingredient analyzed the parameters called linearity and precision (repeatability and intermediate precision). For the chromatographic method applicable to quantitation of the active ingredient in the finished product, parameters such as specificity, precision and accuracy were analyzed. The spectrophotometric method used in the dissolution test took into account specificity, precision, linearity, filtering effect and stability of the analytical solutions.
Results: the evaluation of the performance of the different analytical methods was satisfactory and they proved to be linear, precise and specific in the range of studied concentrations.
Conclusions: the reliability of the methods for the quality control and of the stability studies of the active ingredient and of Cuban-made 100 mg retard sodium diclofenac was demonstrated.


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