A STABILITY-INDICATING HPLC METHOD FOR THE DETERMINATION OF NAPHAZOLINE AND ITS DEGRADATION PRODUCT AND METHYL PARAHYDROXYBENZOATE IN PHARMACEUTICAL PREPARATIONS

Autor: Bodo Lachmann, H. Kopelent-Frank, Ernst Urban, M. Dulavová, T. Korodi
Rok vydání: 2014
Předmět:
Zdroj: Journal of Liquid Chromatography & Related Technologies. 37:1321-1333
ISSN: 1520-572X
1082-6076
DOI: 10.1080/10826076.2013.789802
Popis: A simple, rapid, selective, accurate, and stability-indicating HPLC method for the simultaneous determination of naphazoline and methyl parahydroxybenzoate in pharmaceutical preparations was developed and validated. The method employs a BDS Hypersil C18 column (5 µm; 150 × 4 mm), a mobile phase containing methanol −0.05 M triethylamine plus 10% methanol pH 3 with o-phosphoric acid (30:70, v/v), with a flow rate of 1 mL/min and detection at 254 nm. All the validation parameters (linearity, specificity, accuracy, repeatability, LOD/LOQ) were within the acceptance range and met the ICH Q2(R1) guideline. The stability indicating capability of this method has been demonstrated by separating degradation products as 1-naphthylacetylethylenediamine (impurity A) and 1-naphthylacetic acid (impurity B). Stability tests were performed under alkaline, acidic, neutral, and oxidizing conditions, and with simulated sunlight under standardized conditions in a sun test irradiation chamber. The proposed method was applied f...
Databáze: OpenAIRE
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