Stability indicating HPLC method for the estimation of oxycodone and lidocaine in rectal gel

An HPLC method for the quantification of oxycodone and lidocaine in a gel matrix is described. The mobile phase consisted of methanol–water–acetic acid (35:15:1 v/v/v) and was delivered at 1.5 ml/min through a 4.6×250 mm Zorbax® SB-C8 column. Oxycodone was detected at 285 nm and lidocaine at 264 nm....

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Bibliographic Details
Published in:International journal of pharmaceutics 2001-07, Vol.223 (1), p.49-54
Main Authors: Gebauer, Markus G, McClure, Anna F, Vlahakis, Thean L
Format: Article
Language:English
Subjects:
Administration, Rectal
Analgesics, Opioid - chemistry
Biological and medical sciences
Chromatography, High Pressure Liquid
Drug Stability
Gels
General pharmacology
HPLC
Lidocaine
Lidocaine - administration & dosage
Lidocaine - analysis
Lidocaine - chemistry
Medical sciences
Oxycodone
Oxycodone - administration & dosage
Oxycodone - analysis
Oxycodone - chemistry
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Rectal gel
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Summary:An HPLC method for the quantification of oxycodone and lidocaine in a gel matrix is described. The mobile phase consisted of methanol–water–acetic acid (35:15:1 v/v/v) and was delivered at 1.5 ml/min through a 4.6×250 mm Zorbax® SB-C8 column. Oxycodone was detected at 285 nm and lidocaine at 264 nm. Linear calibration curves were obtained for oxycodone in the range of 0.05–1.5% (w/w) and for lidocaine in the range of 0.1–5.0% (w/w). Oxycodone and lidocaine were treated with hydrogen peroxide and the oxidation products were readily separated on the column. The method was applied to assess the stability of a gel containing oxycodone hydrochloride (0.3% w/w) and lidocaine (1.5% w/w). The gel was stored under refrigeration in ready-to-use syringes and under these conditions oxycodone and lidocaine were stable for at least 1 year. The gel is useful in the management of tenesmus in rectal cancer.
ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(01)00729-3