Capillary gas chromatographic assay of camphor and m-cresol in dermatological creams.
Camphor and m-cresol mixtures are used in antiseptic and anti-itching creams. No compendial method exists for these preparations. This paper reports a capillary gas chromatographic method using FID detection with 2,6-di-tert-butyl-4-methylphenol as internal standard on a 30 m x 0.32 mm Supelcowax -10 column (0.25 micron film) with helium as carrier gas. Ramped temperature programming was applied. The method allows simultaneous quantitation of camphor and m-cresol in the presence of o- and p-cresols, calamine and zinc oxide. Overall percent recoveries (+/- SD, n = 9) of camphor, o-, p- and m-cresol from spiked placebo creams, at a labeled amount of 10 (w/w)% were 96.9 +/- 0.6, 98.2 +/- 0.6, 99.2 +/- 0.5 and 101.0 +/- 0.9%, respectively, and at a labeled amount of 1% were 96.7 +/- 0.6, 97.8 +/- 0.9, 97.8 +/- 0.6, and 100.3 +/- 1.0%, respectively. The recovery studies were carried out at +/- 30% of the labeled amounts. Linear peak area or height ratios were obtained (r > 0.999) for camphor, o-, p- and m-cresol covering a concentration range of 10-200% of the labeled amount. Linearity (r > 0.999) was also obtained for m-cresol when the relative concentration of o- and p-cresol was varied from 5 to 100% of the m-cresol concentration. The resolution between the 'critical pair' of p- and m-cresol was > or = 1.1. The limit of quantitation was 23 pg for m-cresol and 9.3 pg for camphor using an injection split of 1:50. The repeatability (%RSD) for all compounds were < 2% for peak area and < 1.4% for peak height ratios. System suitability and robustness of the method were established. The method was successively applied to the assay of available commercial products and allows assay of camphor and the three cresol isomers.
Mirza
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Division of Pharmaceutical Sciences, College of Pharmacy, University of Cincinnati Medical Center, OH 45267-0004, USA.
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D000982:Antipruritics / Q000032:analysis*; D002164:Camphor / Q000032:analysis*; D002849:Chromatography, Gas / Q000379:methods*; D003408:Cresols / Q000032:analysis*; D003879:Dermatologic Agents / Q000737:chemistry*; D004348:Drug Labeling; D009824:Ointments / Q000737:chemistry; D015203:Reproducibility of Results
D000982:Antipruritics; D003408:Cresols; D003879:Dermatologic Agents; D009824:Ointments; C032538:4-cresol; D002164:Camphor; C042041:3-cresol; C034047:2-cresol