HPLC METHOD DEVELOPMENT AND VALIDATION: SIMULTANEOUS DETERMINATION OF ACTIVE INGREDIENTS IN COUGH AND COLD PHARMACEUTICALS


Hatice Çağlar, Ebru Büyüktuncel

Abstract


Objective: This study aimed to develope a simple reversed-phase high performance chromatographic method for simultaneous determination of pseudoephdrine HCI, pheniramine maleate, acetaminophen, guaifenisin, pyrilamine maleate, chlorpheniramine maleate, triprolidine HCI, dextromethorphan HBr, diphenhydramine HCI in cough and cold pharmaceuticals.

Methods: The separation of these compounds was achieved within 37.9 min on a Nucleodur gravity C18 column (250 x 4.0 mm, 5μm). The chromatographic separation of these compounds performed in a single run by using isocratic mobile phase consisting of methanol:buffer mixture (38:62, v/v) at room temperature, with flow rate of 0.75 mL.min-1.

An ultraviolet absorption at 210 nm was monitored. 2,4,6-trimethoxybenzaldehyde was used as an internal standard (ISTD). The selectivity, linearity of calibration, accuracy, intraday and interday precision and forced degradation studies were examined as parts of the method validation.

Results: The concentration–response relationship was linear over a concentration range of 0.2-250 µg.mL-1 for acetaminophen, 0.5–250 µg.mL-1 for pseudoephdrine HCI and pheniramine maleate, 1–250 µg.mL-1 for guaifenisin, 2.5-250 µg.mL-1 for chlorpheniramine maleate and triprolidine HCI, 5-250 µg.mL-1 for pyrilamine maleate and diphenhydramine HCI, 10-20 µg.mL-1 for dextromethorphan HBr with correlation coefficients better than 0.9993. The relative standard deviations of the intraday and interday were all less than 4%. Conclusion: The proposed liquid chromatographic method was successfully applied for the routine analysis of these compounds in different cough and cold pharmaceutical preparations such as syrups and tablets.

 


Keywords


High performance liquid chromatography, Active Ingredients Cough and Cold Pharmaceuticals, Validation.

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About this article

Title

HPLC METHOD DEVELOPMENT AND VALIDATION: SIMULTANEOUS DETERMINATION OF ACTIVE INGREDIENTS IN COUGH AND COLD PHARMACEUTICALS

Keywords

High performance liquid chromatography, Active Ingredients Cough and Cold Pharmaceuticals, Validation.

Date

01-11-2014

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 6, Issue 10, 2014 Page: 421-428

Online ISSN

0975-1491

Statistics

3088 Views | 1959 Downloads

Authors & Affiliations

Hatice Çağlar
İnönü University Faculty of Pharmacy Department of Analytical Chemistry
Turkey

Ebru Büyüktuncel
İnönü University Faculty of Pharmacy Department of Analytical Chemistry
Turkey

 

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