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2014, Number 3

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Rev Cubana Farm 2014; 48 (3)

Validation of the quality control method for sodium dicloxacillin in Dicloxen capsules

Rodríguez HY, Pérez NM, Suárez PY

Language: Spanish
References: 18
Page: 382-395
PDF size: 215.06 Kb.


ABSTRACT

Introduction: sodium dicloxacillin is a semi synthetic derivative of the isoxasocyl penicillin group that may appear in oral suspension form and in caplets. For the analysis of the raw materials and the finished products, it is recommended to use high performance liquid chromatograpy that is an unavailable method at the dicloxen capsule manufacturing lab for the routine analysis of the drug.
Objective: to develop and to validate a useful ultraviolet spectrophotometry method for the quality control of sodium dicloxacillin in Dicloxen capsules.
Methods: a direct ultraviolet spectrophotometry was developed on the basis of determination of aqueous solution of the analyte at 274 nm distance; the latter was a change from the original detection method set by the Japanese pharmacopeia, 2011 for the raw materials. Since this was a modified method, it had to be validated through parameters such as linearity, precision, accuracy and specificity versus the components of Dicloxen capsule formulation.
Results: the preset 100 % concentration in the suggested procedure was 0.3 mg/mL of analyte, which is in line with the adequate response measured in this test. The ultraviolet spectrum of sodium dicloxacillin showed two maximum absorption values, λmaximun= 274 nm and 283 nm. The choice was λ= 274 nm for quantitation. The set analytical methodology was very simple and allowed obtaining a transparent solution from the finished form, which had a concentration value similar to that of the reference solution. The compliance with all the set acceptance criteria for specificity, linearity, accuracy and precision allowed demonstrating the validity of the method under study for the quality control of sodium dicloxacillin in Dicloxen capsules in the 80-120 % range.
Conclusions: the ultraviolet spectrophotometry method proved to be specific, linear, accurate and precise for the quality control of sodium dicloxacillin in Dicloxen capsules.


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