학술논문
Stability-indicating RP-HPLC method for simultaneous determination of methoxsalen and p-aminobenzoic acid in binary combination
Document Type
Report
Author
Source
Bulletin of the Chemical Society of Ethiopia. January 1, 2015, p27, 13 p.
Subject
Language
English
ISSN
1011-3924
Abstract
INTRODUCTION Methoxsalen is chemically designated as 9-methoxy-7H-furo-(3,2-g)-1-benzopyran (7) one. It is a photosensitizer that greatly increases the skin reactivity to long wavelength ultraviolet radiations (320 to 400 nm). It is [...]
An accurate, simple and specific reverse phase LC procedure is established and validated for simultaneous estimation of methoxsalen and p-aminobenzoic acid in pharmaceutical formulated products and human serum. Chromatographic separation among methoxsalen, p-aminobenzoic acid and their degradation products have been achieved in less than 5 min with Hypersil-ODS column (250 mm x 4.6 mm, 5 µm), using acetonitrile and 1.28 mM phosphate buffer as mobile phase (60:40 v/v). Flow rate of the mobile phase was set as 1.5 mL [min.sup.-1] and detection of all the analytes was carried out by diode-array detector at 254 nm. The developed method was validated according to ICH guidelines by performing its linearity, accuracy, precision, specificity, robustness and LOD/LOQ values. Response was linear and proportional to the concentrations (24-48 µg [mL.sup.-1]) for p-aminobenzoic acid and (9-18 µg [mL.sup.-1]) for methoxsalen. The LOD was 2.3 ng [mL.sup.-1] for p-aminobenzoic acid and 6 ng [mL.sup.-1] for methoxsalen whereas LOQ was 7.8 ng [mL.sup.-1] for p-aminobenzoic acid and 20.4 ng [mL.sup.-1] for methoxsalen. The developed method efficiently separated the principal peaks from degradation products and therefore can be applied successfully for concurrent analysis of methoxsalen and p-aminobenzoic acid in pharmaceutical dosage form, human serum and product stability studies. KEY WORDS: p-Aminobenzoic acid, Methoxsalen, Degradation products
An accurate, simple and specific reverse phase LC procedure is established and validated for simultaneous estimation of methoxsalen and p-aminobenzoic acid in pharmaceutical formulated products and human serum. Chromatographic separation among methoxsalen, p-aminobenzoic acid and their degradation products have been achieved in less than 5 min with Hypersil-ODS column (250 mm x 4.6 mm, 5 µm), using acetonitrile and 1.28 mM phosphate buffer as mobile phase (60:40 v/v). Flow rate of the mobile phase was set as 1.5 mL [min.sup.-1] and detection of all the analytes was carried out by diode-array detector at 254 nm. The developed method was validated according to ICH guidelines by performing its linearity, accuracy, precision, specificity, robustness and LOD/LOQ values. Response was linear and proportional to the concentrations (24-48 µg [mL.sup.-1]) for p-aminobenzoic acid and (9-18 µg [mL.sup.-1]) for methoxsalen. The LOD was 2.3 ng [mL.sup.-1] for p-aminobenzoic acid and 6 ng [mL.sup.-1] for methoxsalen whereas LOQ was 7.8 ng [mL.sup.-1] for p-aminobenzoic acid and 20.4 ng [mL.sup.-1] for methoxsalen. The developed method efficiently separated the principal peaks from degradation products and therefore can be applied successfully for concurrent analysis of methoxsalen and p-aminobenzoic acid in pharmaceutical dosage form, human serum and product stability studies. KEY WORDS: p-Aminobenzoic acid, Methoxsalen, Degradation products