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At least 595 records · Page 33Linked to original sources

Rapid fluorometric determination of procainamide hydrochloride dosage forms.

A fluorometric procedure for procainamide hydrochloride was developed, and it offers improvements in ease, speed, and sensitivity over the official method. The new procedure is based on the reaction with fluorescamine in aqueous medium at pH 7.5 to form a fluorophore, with activation and emission wavelengths of 400 and 485 nm, respectively. The fluorescence is linear (r = 0.999) over the 0. 04-1 mug/ml concentration range and is stable for at least 2 hr. Recovery data appeared to be accurate, quantitative, and reproducible. The overall recovery was 99.8% with a standard deviation of +/-1.14 (n = 5). The method was successfully applied to commercially available dosage forms.

Capsules↗

Improved high-pressure liquid chromatographic method for the analysis of erythromycin in solid dosage forms.

A stability-indicating high-pressure liquid chromatographic (HPLC) method for the assay of erythromycin in enteric film-coated tablets was developed. The method used a reversed-phase column at 70 degrees with a mobile phase of acetonitrile-methanol-0.2 M ammonium acetate-water (45:10:10:35) at pH 7.0. The column were evaluated for the analysis of erythromycin. The HPLC method was also applicable for the analysis of salts and esters of erythromycin. The linearity and precision of the HPLC assay method for erythromycin in the solid dosage form were examined by spiking erythromycin into a tablet placebo a 60-120% of the label. The recovery of erythromycin was 99.9% with a relative standard deviation of less than 1%. The correction factors to express the results of HPLC in terms of antimicrobial bioequivalency against Staphylococcus aureus TCC 6538P for erythromycins A, B, and C were determined to be 1.0, 0.92, and 0.48, respectively. Eight lots of tablets were assayed by the HPLC method, and the results, expressed in terms of erythromycin bioequivalency, showed no statistically significant difference from those of the microbiological assay method.

Bacteria↗

Analysis of Cinchona alkaloids by high-performance liquid chromatography. Application to the analysis of quinidine gluconate and quinidine sulfate and their dosage forms.

The application of high-performance liquid chromatography to resolve the individual alkaloids present in marketed Cinchona alkaloids was investigated. Normal-phase and several reversed-phase systems were evaluated. The proposed procedure uses an alkylphenyl column; it adequately resolves quinidine, quinine, dihydroquinidine, dihydroquinine, cinchonine, cinchonidine, dihydrocinchonine and dihydrocinchonidine. Epiquinidine, epiquinine, quininone and quinitoxine are also resolved from quinidine and dihydroquinidine. This high degree of resolution enables the analysis of quinidine and its salts for their usual composition and establishes the absence of any cross-contamination or decomposition. The proposed procedure was applied to currently marketed samples of quinidine salts and their dosage forms. It was also applied to samples that were cross-contaminated or which contained decomposition products.

Capsules↗

Voltammetric assay of azithromycin in pharmaceutical dosage forms.

The oxidative behaviour of azithromycin was studied at s glassy carbon electrode in different buffer system using cyclic, linear sweep and differential pulse voltammetry. The oxidation process was shown to be irreversible over the entire pH range studied (5-11) and was diffusion-adsorption controlled. Analytical method with adequate precision and accuracy was developed for the determination of azithromycin in phosphate buffer at pH 7 as supporting electrolyte containing 10% methanol and 0.05 M ammonium acetate. The peak current varied linearly with azithromycin concentration in the range 1-15 microg/ml. The procedure was successfully applied for assay of the drug in the pharmaceutical dosage forms. The relative standard deviation (n = 5) of 2.18% was obtained.

Anti-Bacterial Agents↗

Identification and characterization of major degradation products of risperidone in bulk drug and pharmaceutical dosage forms.

Acid, base and oxygen stability of risperidone, a novel anti-psychotic drug, has been evaluated storing the sample in solution phase. One of the major degradation products has been identified and characterized by using techniques namely IR, MS and NMR after isolation by preparative LC. The other major degradation product has been identified with help of MS/MS data and by co-eluting in analytical LC with the available standard. The effect of acid and base resulted in the formation of hydroxy risperidone and the effect of oxygen lead to the formation of N-oxide of risperidone. The two major degradation products in the dosage forms were also characterized as 9-hydroxy risperidone and N-oxide of risperidone, after enrichment through preparative LC, by LC-MS/MS and HPLC. Structural elucidation of degradation product leading to the formation of N-oxide of risperidone is discussed in detail.

Chromatography, Liquid↗

Dissolution studies of some sustained-release theophylline dosage forms.

Dissolution studies were carried out with the USP rotating-basket apparatus in both simulated gastric and intestinal fluids. Four different brands of sustained-release theophylline products of different strengths (nine formulations) were studied. The percentage of the dose released in 1 h in gastric fluid ranged from (mean +/- SD) 6.6 +/- 0.9 to 50.1 +/- 3.8%. By 6 h, the percentage of the dose released ranged from 10.8 +/- 1.8 to 86.5 +/- 5.2%. Similar formulations of different strengths released significantly different fractions of their dose at respective sampling times. In intestinal fluid, some formulations released 100% of their dose within 3-4 h, behaving more like enteric-coated preparations. One dosage form appeared to release drug by an apparent zero-order rate. From one brand of theophylline (two strengths), only 48.1 +/- 5.6 and 29.9 +/- 4.1% of label strength, respectively, dissolved in 25 h in intestinal fluid. Some of these in vitro results were rank-correlated to previously reported bioavailability and pharmacokinetic studies.

Biological Availability↗

The rate and extent of calcium bioavailability from two oral dosage forms in rats.

The purpose of the present work was to compare oral bioavailability of calcium from two calcium preparations, Calcium Sandoz forte 500 mg and Calcium Spofa effervescens. The pharmacokinetic study was carried out on rats, and plasma levels of 45Ca after administration of labelled calcium solutions were determined. Appropriate equations describing the two-compartment open model and the one-compartment model with first order absorption were fitted to the observed i.v. and oral data, respectively, using weighted nonlinear least-squares regression analysis. The extent and the time profile of the rate of 45Ca systemic bioavailability were assessed. Both parameters suggested identical bioavailability of calcium from the two dosage forms compared.

Administration, Oral↗

"Determination of domperidone in tablet dosage form by anodic differential pulse voltammetry".

A differential pulse voltammetric method was described for the determination of domperidone. The method was based on the anodic oxidation of domperidone on a glassy carbon electrode at +0.64 V vs. SCE in Britton-Robinson buffer solution of pH 2.3. The reversibility of the oxidation was tested by cyclic voltammetry; the electrode process is irreversible and diffusion-adsorption controlled. Calibrations are linear over the range 1.0 x 10(-6)-2.0 x 10(-5) M of domperidone with a detection limit of 4.0 x 10(-7) M. The method was applied, without any interference from the excipients, to the determination of the drug in a tablet dosage form.

Antiemetics↗