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The antimicrobial action of 21 pharmaceutical preparations has been compared in vitro by testing them against Staph. aureus (Oxford strain) in an identical environment. While a number of chemicals produced a degree of action, which can be considered adequate for clinical purposes, the combination thymol-camphor gave the best results.
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A fast, reproducible, economical, and dependable automated counter method is recommended for the quality control of pharmaceutical preparations intended for intravenous administration. The USP gives no specifications on the limitations of particulate matter in intravenous products, while the BP specifies limitations on intravenous solutions of more than 500-ml volume. Out of 15 different marketed products, few passed the BP specifications. The microscopically identifiable particles included starch, cellulose fibers, glass, rubber, lacquer flakes, carbon black, and metal shavings. The proposed quality control method introduces a modification to the BP specifications. The method includes a standard log-log plot obtainable from a least-squares line fit to the data of the marketed products showing minimal particle contamination. The standard plot is compared to the experimental data obtained from any other product and, accordingly, it is decided whether the product is acceptable or not.
A simple ultraviolet spectrophotometric method for the determination of phenytoin in pharmaceutical preparations has been developed. The mean was 100.9% (6 determinations) and the coefficient of variation was 1.2%. The method was applied successfully to the determination of phenytoin in capsules and suspensions.
An indirect complexometric method is described for the determination of piperazine alone or in its pharmaceutical preparations. The method involves treatment of the aqueous solution of piperazine with carbon disulphide, ammonia solution and a known excess of cupric acetate, filtration of the formed precipitate and determination of the excess cupric acetate with EDTA using PAR as indicator.
Orthogonal polynomial functions have been used in the simultaneous determination of mixtures of phenytoin and phenobarbitone in pharmaceutical preparations. The mean recovery (9 determinations) and coefficeint of variation were 100-0 +/- 1-4% for phenobarbitone and 100-0 +/-1-3% for phenytoin. Neither the delta A method of Pannerdan & Fontein nor a delta A modification of Vierordt's method of two-component analysis gave results of the same accuracy and precision as the proposed method.
A method is described for the rapid determination of phenothiazine drugs in a wide variety of pharmaceutical preparations. The drugs are determined by a difference spectrophotometric technique based upon the absorbance of the sulphoxide derivative of the drug relative to the absorbance of a solution of the underivatized drug. The sulphoxide derivatives are formed rapidly and quantitatively at room temperature by the addition of a solution of peroxyacetic acid, prepared by the slow reaction of hydrogen peroxide and glacial acetic acid on standing. The difference absorbance of the solutions is proportional to the concentration of the phenothiazine drug in the preparation and is specific for the intact drug in the presence of oxidative and photochemical decomposition products, colouring and flavouring agents, excipients and most co-formulated drugs.
An improved high-pressure liquid chromatographic method for the determination of doxorubicin hydrochloride (Adriamycin TM) in pharmaceutical preparations has been developed. A liquid-solid system using microporous silica (Zorbax) as the stationary phase and 3.8% 0.5 M sodium acetate buffer (pH 4.5) in isopropanol as the mobile phase gave optimum separation of doxorubicin hydrochloride from the excipient (lactose) and minor impurities. The doxorubicin hydrochloride content of a 10-mg vial can be determined in 25-30 min with a relative standard deviation of 3.2%. Results compare favorably with those obtained by established thin-layer chromatography and spectrophotometric procedures. The sensitivity of the method is sufficiently high (nanogram range) for possible use in metabolic or pharmacological studies.
Simple, rapid, and accurate methods have been developed for determining vitamin B1 in pharmaceutical preparations without prior separation of the vitamin. The methods are based on the desulfurization reaction with potassium plumbite and measurement of the unreacted lead(II) ions at 217 nm using atomic absorption spectroscopy (AAS), or by titration with EDTA at pH 4.5 with the lead ion selective electrode and Gran's plot. The results compare favorably with those obtained using the USP fluorometric method. Recoveries of pure vitamin B1 averaged 99.1%, with a standard deviation of 0.8%, and 99.0%, with a standard deviation of 0.7%, for the AAS and ion selective electrode procedures, respectively.
A differential spectroscopy method for the determination of microgram quantities of ergocalciferol, using trifluoroacetic acid and hydrogen peroxide, was applied to commercially available pharmaceutical preparations. Tablets were powdered and extracted with methanol after being made basic with diethylamine. The methanol was concentrated, chloroform was added, and the mixture was chromatographed on neutral alumina using chloroform as the eluent. Ergocalciferol was determined in an aliquot of the eluate by differential spectroscopy and was compared with a reference ergocalciferol standard treated similarly. The method applied to low potency formulations (2.5-6 mug/tablet) is simple and quantitative, needs less than 5 hr for completion, and has a precision of less than +/- 2%. A simple and accurate chromatographic method for the determination of ergocalciferol in stabilized powders and high potency tablets, which precludes the necessity of solvent-solvent extraction, was also developed. The results are comparable with those obtained by the rat bioassay and the USP XVIII chemical assay.
Methods for the determination of organically bound iodine were compared. A preliminary destruction of the sample was preferable. The sample was mineralized using the Schöniger combustion. Since direct potentiometry of the iodide ion was used, further reduction of the sample was necessary. Several reductors were compared, and the best results were obtained with Devarda alloy. The proposed method was amployed for the determination of iodine in X-ray contrast products. Pure compounds and pharmaceutical preparations were investigated. The coefficient of variation of the method was 0.9%.
Ion-pair partition has been combined with HPLC for the rapid detection and separation of the major anthraquinone glycosides of senns, sennosides A and B. A Corasil C18 column (5 microns) with methyl alcohol (30 percent in water) containing 0.005 M tetrabutylammonium phosphate, pH 7.5, as mobile phase was used. In the application to the assay of drugs, sennosides A and/or B constituents of the crude senna drug, Senokot syrup, Senokot tablets, and Pursennid tablets have been estimated in the presence of other constituents of the crude drug and pharmaceutical preparations. The results obtained are compared with colorimetric assay results.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.