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At least 19 recordsLinked to original sources
PubMed2005

Application of a capillary electrophoresis method for simultaneous determination of preservatives in pharmaceutical formulations.

Preservatives are used to protect pharmaceutical formulations from microbial attack during the period of administration to the patient. Because of their biological activity, preservatives have to be identified and assayed according to the same rules as apply to active components. A number of methods for separation of preservatives are reported, to account for the heterogeneity of their chemical structures. A capillary electrophoretic method was devised for simple and simultaneous qualification and quantification of the preservatives most often included in pharmaceuticals, such as benzyl alcohol, parabens, phenol, m-cresol, chlorobutanol, thimerosal. After systematic method development, the electrophoretic conditions were defined as: 50 mM borate buffer pH 9.0 containing 20 mM SDS. Separations were performed at a temperature of 20 degrees C and with detection at 214 nm. Preservatives under examination can be analyzed within a 10 min run. The method was successfully validated and applied to the determination of preservatives in a number of pharmaceuticals. Results from the CE method were compared with those from reference methods.

Benzyl Alcohol↗
PubMed1978

Detection of preservatives in pharmaceutical and cosmetic products using agar gel electrophoresis.

A method is described using high voltage agar gel electrophoresis for the separation and microbiological detection of preservatives in pharmaceutical and cosmetic products. The positions of the preservatives were detected as zones of inhibition of a test organism within the nutrient agar gel and can be characterised by their migration, shape and presence of a halo. A wide range of preservatives commonly used in pharmaceutical and cosmetic preparations could be detected in low concentrations. The method however was not suitable for certain volatile preservatives and many primarily antifungal compounds could be detected above their use concentration.

Cosmetics↗
PubMed1997

Chlorobutanol: maternal serum levels and placental transfer in the mouse.

Chlorobutanol (CB) is a pharmaceutical preservative and the active ingredient in certain sedatives and anesthetics and produces adverse effects in adult tissues and mouse embryos in vitro. Chlorobutanol is slowly eliminated in humans, but little is known about its serum levels in other species or placental transfer in any species. Pregnant mice gavaged with 80 mg CB/kg on gestational day (gd) 9.5 provided serum at 10 min to 36 h post-dosing for a time course study. Additional mice gavaged with 0, 8, 40 or 80 mg CB/kg on gd 9.5 provided maternal serum and embryos 2 h post-dosing for a placental transfer study, and CB levels were measured using capillary gas chromatography with electron capture detection. Dosing with 80 mg CB/kg produced maternal serum levels between 30.8 micrograms/mL (10 min) and < 1 microgram/mL (36 h), with a half-life of 7.45 h. Embryonic CB levels increased with maternal dose and were correlated with maternal serum levels. Serum levels of CB in the mouse appeared to follow a time course similar to humans, with rapid absorption and slow elimination. Placental transfer, as demonstrated here in the mouse, may allow embryonic accumulation of CB to potentially toxic levels.

Administration, Oral↗
PubMed2003

Comparing micellar electrokinetic chromatography and microemulsion electrokinetic chromatography for the analysis of preservatives in pharmaceutical and cosmetic products.

In this study, separation and determination of nine preservatives ranging from hydrophilic to hydrophobic properties, which are commonly used as additives in various pharmaceutical and cosmetic products, by micellar electrokinetic chromatograpy (MEKC) and microemulsion electrokinetic chromatography (MEEKC) were compared. The effect of temperature, buffer pH, and concentration of surfactant on separation were examined. In MEKC, the separation resolution of preservatives improved markedly by changing the sodium dodecyl sulfate concentration. Temperature and pH of running buffers were used mainly to shorten the magnitude of separation time. However, in order to detect all preservatives in a single run in a MEEKC system, a microemulsion of higher pH was needed. The separation resolution was improved dramatically by changing temperature, and a higher concentration of SDS was necessary for maintaining a stable microemulsion solution, therefore the separation of the nine preservatives in MEEKC took longer than in MEKC. An optimum MEKC method for separation of the nine preservatives was obtained within 9.0 min with a running buffer of pH 9.0 containing 20 mM SDS at 25 degrees C. A separation with baseline resolution was also obtained within 16 min using a microemulsion of pH 9.5 which composed of SDS, 1-butanol, and octane, and a shorter capillary column at 34 degrees C. Finally, the developed MEKC and MEEKC methods determined successfully preservatives in various cosmetic and pharmaceutical products.

Buffers↗
PubMed1986

Reversed-phase determination of famotidine, potential degradates, and preservatives in pharmaceutical formulations by high-performance liquid chromatography using silica as a stationary phase.

An analytical method was developed for the determination of famotidine, potential degradates, and preservatives in several pharmaceutical formulations. The method employs reversed-phase chromatography on a silica column with a methanol-phosphate solution as the mobile phase. The influence of the concentration of phosphate and organic modifier are discussed. Accuracy and precision for this method along with assay data from different formulations of famotidine are presented. Two different commercial silica columns were tested with this method. Chromatographic differences related to the surface area and pore size of the silica are discussed.

Chemistry, Pharmaceutical↗