A validated stability-indicating HPLC method for the simultaneous determination of pheniramine maleate and naphazoline hydrochloride in pharmaceutical formulations

Chemistry Central Journal

Taomin Huang²  Nianzu Chen²  Donglei Wang²  Yonghua Lai²  Zhijuan Cao¹ 

[1] School of Pharmacy, Fudan University, Zhangheng Road, No. 826, Shanghai 201203, People’s Republic of China

[2] Department of Pharmacy, Eye Ear Nose Throat Hospital of Fudan University, Fenyang Road, No. 83, Shanghai 200031, People’s Republic of China

关键词: Degradation products;    Naphazoline hydrochloride;    Pheniramine maleate;    Method validation;    Liquid chromatography;   

Others  :  787804
DOI  :  10.1186/1752-153X-8-7

 received in 2013-09-23, accepted in 2014-01-27,  发布年份 2014

【 摘 要 】

Background

A simple, rapid, and accurate stability-indicating reverse phase liquid chromatographic method was developed and validated for the simultaneous determination of pheniramine maleate and naphazoline hydrochloride in bulk drugs and pharmaceutical formulations.

Results

Optimum chromatographic separations among pheniramine maleate, naphazoline hydrochloride and stress-induced degradation products have been achieved within 10 minutes by using an Agilent zorbax eclipse XDB C18 column (150 mm × 4.6 mm, 5 μm) as the stationary phase with a mobile phase consisted of 10 mM phosphate buffer pH 2.8 containing 0.5% triethlamine and methanol (68:32, v/v) at a flow rate of 1 mL min^-1. Detection was performed at 280 nm using a diode array detector. Theoretical plates for pheniramine maleate and naphazoline hydrochloride were calculated to be 6762 and 6475, respectively. The method was validated in accordance with ICH guidelines with respect to linearity, accuracy, precision, robustness, specificity, limit of detection and quantitation. Regression analysis showed good correlations (R² > 0.999) for pheniramine maleate in the concentration range of 150–1200 μg mL^-1 and naphazoline hydrochloride in 12.5-100 μg mL^-1. The method results in excellent separation of both the analytes and degradation products. The peak purity factor is ≥980 for both analytes after all types of stress, indicating complete separation of both analyte peaks from the stress induced degradation products.

Conclusions

Overall, the proposed stability-indicating method was suitable for routine quality control and drug analysis of pheniramine maleate and naphazoline hydrochloride in pharmaceutical formulations.

【 授权许可】

   
2014 Huang et al.; licensee Chemistry Central Ltd.

【 图 表 】

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