Validation of the spectrophotometric determination of omeprazole and pantoprazole sodium via their metal chelates

Salama, Fathy M.; El-Abasawy, Nasr M.; Razeq, Sawsan A. Abdel; Ismail, Magda M. F.; Fouad, Mostafa A.

doi:10.1016/s0731-7085(03)00233-4

Cited by 63 publications

(33 citation statements)

References 11 publications

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“…Several methods have been developed for determination, chiral separation, stability, or pharmacokinetic studies of 2 in bulk form, pharmaceuticals or biological samples, and these methods may include different spectrophotometric methods via formation of metal chelates [14], UV-derivative spectrophotometry [15] and HPLC methods for its determination [16], separation of enantiomers [17], for stability studies [18], or for the study of its pharmacokinetic profile [19].…”

Section: Introductionmentioning

confidence: 99%

Fluorometric Determination of Drugs Containing α-Methylene Sulfoxide Functional Groups Using - Methylnicotinamide Chloride as a Fluorogenic Agent

Elokely

Eldawy

Elkersh

et al. 2012

ISRN Analytical Chemistry

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A simple fluorometric method, using N 1 -methylnicotinamide chloride (NMNCl) as a fluorogenic reagent, has been developed, adapted, and validated for the quantitative estimation of drugs containing α-methylene sulfoxide functional groups. The proposed method has been applied successfully to the determination of sulindac (1), omeprazole (2), lansoprazole (3), pantoprazole (4), and rabeprazole (5) in the pure form, laboratory-prepared mixtures, pharmaceutical dosage forms, spiked human plasma samples, and in hospitalized patient's or volunteer's blood. For the standard solutions of 1, 2, 3, 4, and 5, the method showed linearity over concentration ranging between 1-50 μg/mL, 50-1200 ng/mL, 100-1500 ng/mL, 10-1500 ng/mL, and 20-2200 ng/mL, respectively. For the spiked human plasma of 1, 2, 3, 4, and 5, the linearity was shown over concentration ranging between 1-50 μg/mL, 75-1200 ng/mL, 100-1400 ng/mL, 10-1500 ng/mL, and 50-2100 ng/mL, respectively. The method showed good accuracy, specificity, and precision in both laboratory-prepared mixtures and spiked human plasma samples. The proposed method is simple, does not need sophisticated instrumentation, suitable for quality control application, bioavailability, and bioequivalency studies. Besides, the sensitivity and detection limits are comparable to sophisticated chromatographic methods.

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Section: Introductionmentioning

confidence: 99%

Fluorometric Determination of Drugs Containing α-Methylene Sulfoxide Functional Groups Using - Methylnicotinamide Chloride as a Fluorogenic Agent

Elokely

Eldawy

Elkersh

et al. 2012

ISRN Analytical Chemistry

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“…The other conventional spectrophotometric methods using FeCl3 10 and eosin and copper 11 need longer times to record the absorbance, whereas the method utilizing 2,3-dichloro-5,6-dicyano-1,4-benzoquinone 11 gives a stable color instantaneously. The drawback of these methods is that they employ an organic solvent while the proposed kinetic method is carried in an aqueous system.…”

Section: Applicability Of the Proposed Kinetic Methodsmentioning

confidence: 99%

“…Two derivative spectrophometric procedures 8,9 have been described for the determination of pantoprazole in drug formulations. The drug content in pharmaceutical preparations has been determined spectrophotometrically 10 in the visible region based on the reaction of drug with Fe(III) to form an orange-colored chelate, which absorbed maximally at 455 nm. The drug forms a ternary complex with eosin and copper, which is a basis for its analysis at 549 nm.…”

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confidence: 99%

Kinetic Spectrophotometric Analysis of Pantoprazole in Commercial Dosage Forms

2006

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“…This drug is poorly soluble in water and sensitive to heat, moisture, organic solvents, and, to some degree, light (18,19). OME shows low physicochemical stability at acidic conditions, degrades very rapidly in the stomach and undergoes hepatic first-pass metabolism (20)(21)(22), with a bioavailability not exceeding 35%. All these drawbacks give rise to difficulties in obtaining an oral pharmaceutical formulation with an acceptable bioavailability.…”

Section: Introductionmentioning

confidence: 99%

A Comprehensive Development Strategy in Buccal Drug Delivery

2010

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Abstract. This work combines several methods in an integrated strategy to develop a matrix for buccal administration. For this purpose, tablets containing selected mucoadhesive polymers loaded with a model drug (omeprazole), free or in a complexed form with cyclodextrins, and in the absence and presence of alkali agents were subjected to a battery of tests. Mucoadhesion studies, including simple factorial analysis, in vitro release studies with both model-dependent and model-independent analysis, and permeation studies were performed. Mucoadhesive profiles indicated that the presence of the drug decreases the mucoadhesion profile, probably due its hydrophobic character. In tablets loaded with the drug complexed with β-cyclodextrin or methyl-β-cyclodextrin, better results were obtained with the methylated derivative. This effect was attributed to the fact that in the case of β-cyclodextrin, more hydroxyl groups are available to interact with the mucoadhesive polymers, thus decreasing the mucoadhesion performance. The same result was observed in presence of the alkali agent (L-arginine), in this case due to the excessive hydrophilic character of L-arginine. Drug release from tablets was also evaluated, and results suggested that the dissolution profile with best characteristics was observed in the matrix loaded with omeprazole complexed with methyl-β-cyclodextrin in the presence of L-arginine. Several mathematical models were applied to the dissolution curves, indicating that the release of the drug, in free or in complexed state, from the mucoadhesive matrices followed a super case II transport, as established on the basis of the Korsmeyer-Peppas function. The feasibility of drug buccal administration was assessed by permeation experiments on porcine buccal mucosa. The amount of drug permeated from mucoadhesive tablets presented a maximum value for the system containing drug complexed with the methylated cyclodextrin derivative in presence of L-arginine. According to these results, the system containing the selected polymer mixture and the drug complexed with methyl-β-cyclodextrin in presence of L-arginine showed a great potential as a buccal drug delivery formulation, in which a good compromise among mucoadhesion, dissolution, and permeation properties was achieved.

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Validation of the spectrophotometric determination of omeprazole and pantoprazole sodium via their metal chelates

Cited by 63 publications

References 11 publications

Fluorometric Determination of Drugs Containing α-Methylene Sulfoxide Functional Groups Using - Methylnicotinamide Chloride as a Fluorogenic Agent

Fluorometric Determination of Drugs Containing α-Methylene Sulfoxide Functional Groups Using - Methylnicotinamide Chloride as a Fluorogenic Agent

Kinetic Spectrophotometric Analysis of Pantoprazole in Commercial Dosage Forms

A Comprehensive Development Strategy in Buccal Drug Delivery

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