Search results for "SAGE"

2020

In this study, the potential for correlation between disintegration and dissolution performance of enteric-coated (EC) dosage forms was investigated. Different enteric hard shell capsule formulations containing caffeine as model drug were tested for disintegration (in a compendial disintegration tester) and for dissolution in both USP type I (basket) and type II (paddle) apparatuses using different media. Overall, good correlations were obtained. This was observed for both the basket and the paddle apparatus, indicating that the use of disintegration testing as a surrogate for dissolution testing (allowed by International Conference on Harmonization (ICH) for immediate release dosage forms …

Determination of Anticonvulsant Drugs in Pharmaceutical Preparations by Micellar Liquid Chromatography

2004

A micellar liquid chromatographic method for quality control of pharmaceutical preparations (capsules, pills, tablets, injections, drops, and suppositories) containing the anticonvulsant drugs acetazolamide, carbamacepine, chlordiazepoxide, diazepam, ethosuximide, phenytoin, phenobarbital, and zopiclone has been developed. This methodology involves the use of micellar solutions of cetyltrimethylammonium bromide (CTAB) as mobile phases and UV detection. The proposed approach is rapid and reproducible. Sample preparation only requires dissolution with micellar solvent and adequate dilution with the mobile phase before injection into the chromatographic system.

Novel insights into excipient effects on the biopharmaceutics of APIs from different BCS classes: Lactose in solid oral dosage forms

2014

Excipients encompass a wide range of properties that are of importance for the resulting drug product. Regulatory guidelines on biowaivers for immediate release formulations require an in depth understanding of the biopharmaceutic effects of excipients in order to establish bioequivalence between two different products carrying the same API based on dissolution tests alone. This paper describes a new approach in evaluating biopharmaceutic excipient effects. Actually used quantities of a model excipient, lactose, formulated in combination with APIs from different BCS classes were evaluated. The results suggest that companies use different (relative) amounts depending on the characteristics o…

Rapid method for analysis of nicotine and nicotine-related substances in chewing gum formulations

1998

Abstract Based on environmental requirements and demands for a high throughput a rapid method for the analysis of nicotine and nicotine-related substances in chewing gum formulations was developed. The method is based on sample preparation through liquid–liquid extraction followed by reversed-phase HPLC using gradient elution. It allowed up to nine analytes to be determined within 15 min, including the sample preparation, and was considered as accurate and robust.

Continuous-flow spectrophotometric determination of sulfadiazine by diazotisation with in situ preparation of nitrite

1995

Abstract Nitrite is prepared in situ for the determination of sulfadiazine. The method is based on solid-phase reduction of copperized cadmium of nitrate; the nitrite reagent merges with the sample stream in hydrochloric acid medium and the resulting mixture is injected into the water carrier, pure distilled water, and then merges with the N-(1-naphthyl)ethylendiamine reagent and is measured spectrophotometrically at 542.0 nm. The calibration graph is linear over the range 0.5–50 μg ml−1 sulfadiazine, mid-range R.S.D. = 0.3% (n = 5) and sample throughput 72 h−1. The procedure is applied to sulfadiazine determination in a pharmaceutical formulation and to in vitro dissolution studies of two …

Spectrophotometric Determination of Hydralazine with 2-Hydroxy-1-naphthaldehyde in Pharmaceuticals

1991

Abstract A new extraction-spectrophotometric method for the determination of hydralazine, based on its reaction with 2-hydroxy-1-naphthaldehyde at 25 °C, is described. The calibration curve was linear between 0.4 and 6 mg/mL of hydralazine. The molar absorbtivity of the product at 408 nm is 40 900 L · mol − 1 · cm − 1 . The method described was applied to the analysis of hydralazine in pharmaceutical preparations containing reserpine, hydrochlorothiazide, bendrofluorthiazine, propranolol, and other substances. The agreement with the U.S.P. XXI method was satisfactory for tablets and injections, but not for pellets.

Simultaneous dissolution profiles of two drugs in pharmaceutical formulations by an FIA manifold

2002

Abstract This article deals with the simultaneous determination of dissolution profiles of two drugs with overlapped spectra, present in the same pharmaceutical formulation. The official procedure for the dissolution profile is adapted to the continuous-flow methodology; the dissolution vessel is connected to an FIA manifold, in which the sample aliquots from the dissolution vessel are treated in order to adjust to the suitable pH and dilution degree to be monitored. The resulting solution is injected into the carrier stream, an acetic acid–acetate buffer at pH 4.3 and forced to the flow-cell of the spectrophotometer. The simultaneous determination of both profiles is based on the first der…

Supercritical Fluid Extraction and Supercritical Fluid Chromatography of Vitamin E in Pharmaceutical Preparations

1999

Flow injection-spectrophotometric determination of metoclopramide hydrochloride.

1997

Abstract The determination of metoclopramide hydrochloride is spectrophotometrically determined by the Bratton-Marshall method in a flow injection assembly. The required nitrite is prepared on-line in the flow assembly by reducing a nitrate solution with the aid of a copperised cadmium solid-phase reactor. The calibration graph is linear over the range 0.5–85 mg l−1, with a relative standard deviation (RSD) of 0.89%, and sample throughput of 51 samples h−1. The method is easy and simple, and it is applied to determination of metoclopramide in some pharmaceutical formulations. The method eliminates the need for frequent preparation of unstable nitrite solutions.

Comparative Study on the Determination of Cephalexin in its Dosage Forms by Spectrophotometry and HPLC with UV-vis Detection

1997

This paper discusses the spectrophotometric determination of cephalexin as the intact cephalexin or as its acid-induced degradation product. Cephalexin can be determined in the range 1 × 10−5−18 × 10−5M with relative standard deviations of 5-1%. The limits of quantitation and detection were 10−5 and 0.3 × 10−5M, respectively. These procedures were compared with reversed-phase HPLC determination. No interference was observed in the presence of common pharmaceutical adjuvants. The H-point standard additions method was applied in order to correct for the possible presence of the cephalexin precursor, 7-aminocephalosporanic acid; this improves the selectivity of the UV-vis spectrophotometric me…