Optimization and Validation of an RP-HPLC Method for Analysis of Hydrocortisone Acetate and Lidocaine in Suppositories

Authors: Jancic-Stojanovi, Biljana¹; Malenovi, Andjelija¹; Markovi, Slavko²; Ivanovi, Darko¹; Medenica, Mirjana³

Source: Journal of AOAC International, Volume 93, Number 1, January 2010 , pp. 102-107(6)

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Abstract:

An RP-HPLC method has been optimized and validated for the simultaneous determination of hydrocortisone acetate and of lidocaine in suppositories. For the method optimization, response surface methodology was applied, and the obtained model was tested using analysis of variance. The optimal separations were conducted on a Beckman-Coulter 150 4.6 mm, 5 m particle-size column at 20C. The mobile phase was methanolwater (65 + 35, v/v), pH adjusted to 2.5 with 85 orthophosphoric acid, with a flow rate of 1.0 mL/min. UV detection was performed at 250 nm. Phenobarbital was used as an internal standard. The method was validated for selectivity, linearity, precision, and robustness.

Document Type: Research article

Affiliations: 1: University of Belgrade, Faculty of Pharmacy, Department of Drug Analysis, Vojvode Stepe 450, 11 152 Belgrade, Serbia. 2: Medicines and Medical Devices Agency of Serbia, Vojvode Stepe 458, 11 152 Belgrade, Serbia. 3: University of Belgrade, Faculty of Pharmacy, Department of Physical Chemistry, Vojvode Stepe 450, 11 152 Belgrade, Serbia.

Publication date: 2010-01-01

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The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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Optimization and Validation of an RP-HPLC Method for Analysis of Hydrocortisone Acetate and Lidocaine in Suppositories

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