García PC, Salomón IS, Montes de Oca PY

Language: Spanish
References: 9
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ABSTRACT

Introduction: Paracetamol is an effective analgesic and antipyretic drug of the non-steroidal anti-inflammatory drug group. Paracetamol oral drops are indicated for use in infant population aged up to 5 years to relieve fever, headache, toothache and symptomatic relief of common cold.
Objective: To validate two analytical methods for the quality control and the stability study and to study the stability of 100 mg/ml Paracetamol oral drops made in Cuba.
Methods: For quantification of the active principle in the final product in order to study stability, a chromatographic column equipment called Lichrosorb RP-18 was used for separation (5µm) (250 x 4 mm), with ultraviolet ray detection at 243 nm and a mobile phase made up of distilled water: methanol (3:1) and the quantification of this principle against a reference sample by using the external standard method. For the quality control, the spectrophotometry used the spectrophotometer SPECTRONIC GENESYS 2, the ideal wavelength was 245 nm since it matches the maximum absorption rate and there is no interference with the excipients. As to the stability study of the drops, the on- shelf life method (temperature below 30 C) was used, and for the accelerated stability analysis (40 ± 2ºC) through high performance liquid chromatography.
Results: The results of the evaluated parameters in the validation of the methods for the quality control and the stability study were within the set limits. The results of the stability study, both accelerated and on- shelf life and reservoir use, showed that the final product met the quality specifications during the study.
Conclusions: The analytical methods based on UV spectrophotometry and high performance liquid chromatography are valid for the quality control and the stability study of 100 mg/ml Paracetamol oral drops, since they are linear, precise, accurate and specific. The physical, chemical and microbiological stability of the product was proved for 12 months at a temperature below 30ºC, packed in 15 ml amber glass reservoirs, 18mm opening and hydrolytic quality III. The product is also stable for 30 days after opening the reservoir.

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