Summary The application of GLC, HPLC and TLC to the analysis of pharmaceutical creams is discussed with special attention to sample clean-up. The results of the determination of hydrocortisone acetate, salicylic acid, benzoic acid, diethyl stilbestrol, chloramphenicol, diphenhydramine HCl, tretinoin and some cream base components by reversed phase HPLC are given.Presented at the 14th International Symposium on Chromatography London, September, 1982 相似文献
The integrity of liposomes when dispersed in presence of various common formulation excipients is studied. Additionally, the effect of the excipients on the release of calcein from the same liposomes when dispersed in hydrogels is investigated and the results of the two sets of experiments are compared. Propyleneglycol (PG), transcutol CG (TR), cremophor EL (CR) and labrafac hydro WL 1219 (LB) are used at 10 or 25% (v/v) and the retention of liposome encapsulated calcein is followed for 24 or 48 h periods. Calcein entrapping multilamellar liposomes composed of phosphatidylcholine (PC) or 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) with or without addition of different amounts of cholesterol (Chol) were prepared by the thin film hydration method.
Experimental results reveal that liposomes are affected more by the excipients in the order: LB > CR > PG TR. Particularly LB and in some cases also CR result in rapid release of most or the entire vesicle encapsulated dye. Addition of Chol in both PC and DSPC liposomes results in substantial increase of vesicle integrity in all cases. Concerning the release of calcein form the liposomal gels, from DSPC/Chol (1:1) liposomal gels calcein release was not affected by addition of 25% of TR or PG in all gels studied, but LB caused a significant increase in calcein release. However, from PC-liposomal gels even TR and PG (at 25%), increases calcein release.
Conclusively, the results of this study suggest that liposomes are protected from excipients when dispersed in gels compared to aqueous media. This should be taken into account when liposomal drug formulations are designed. 相似文献
The ionic liquid (IL), tetrakis (2-hydroxyethyl) ammonium triflouromethanesulfonate is rationally designed for horseradish peroxidase (HRP) on the basis of its stability and activity in the presence of an excipient, tris(hydroxymethyl)aminoethane (TRIS) in different ILs. The activity of HRP in this tailor made IL is at least 30-240-fold higher than that in conventional ILs. Also, the activity is more than 10 times greater than that in methanol, a common organic solvent used for HRP. 相似文献
Formulators do not naturally turn to statistical thermodynamics for experimental inspiration. However, with the newer, intuitive approach to statistical thermodynamics, the formulator gains deep insights into the hitherto confusing effects of ‘cosolvents’, ‘hydrotropes’, ‘solubilizers’ that affect properties such as solubility, gelation or conformational stability. The historical confusion has arisen from classical approaches that simply cannot disentangle causes and effects. The aim of this review is to demonstrate how a formulator can work with statistical thermodynamics towards a rational design of experiments and an unambiguous interpretation of the driving forces behind cosolvent effects. 相似文献
Summary The use of capillary electrophoresis for the separation and quantitation of a range of pharmaceutical raw materials and excipients is reviewed. Capillary electrophoresis is shown to be a useful and versatile technique for a large number of applications. Features of the various methods include simplicity, detection of poor chromatophore species by extensive use of indirect UV detection or direct absorbance at low wavelengths, minimal operating costs and generation of high quality retrievable raw data. Specific novel examples described include separations of lactose, flavouring agents, inorganic salts, lecithin constituents, a range of organic acids, benzylalkonium chloride components, sodium lauryl sulphate, and the quality of input water. It is concluded that the versatility of CE will ensure that it is increasingly used in the analysis of pharmaceutical raw materials and excipients. 相似文献
This study demonstrates the use of hydrophilic interaction liquid chromatography (HILIC) for the separation of both active and inactive ingredients in pharmaceuticals from a single injection. Excipients commonly used in parenteral formulations were separated using a gradient method employing increasing aqueous composition. An evaporative light-scattering detector (ELSD) provided direct detection of inactive excipients and inorganic salts lacking UV chromophores. Analyses of Gemzar parenteral formulations using optimized isocratic HILIC-ELSD method conditions were performed based on retention time screening from the gradient assay. All of the components were efficiently separated using a TSK-Gel Amide 80 column including gemcitabine, mannitol, and sodium cation demonstrating the qualitative capability of the technique. The method was thoroughly validated for mannitol content to access the quantitative potential of the technique. Validation parameters included linearity, accuracy, specificity, solution stability, repeatability, and intermediate precision. Overall, the method described in this report proved to be very robust and represents a novel technique to conveniently separate and detect the active and inactive components in pharmaceuticals both quickly and accurately. 相似文献