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J Pharm Biomed Anal. 2000 Feb;22(1):45-58.

Spectrophotometric methods for the determination of lansoprazole and pantoprazole sodium sesquihydrate.

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1
Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Egypt.

Abstract

Spectrophotometric procedures for determination of two irreversible proton pump inhibitors, lansoprazole (I) and pantoprazole sodium sesquihydrate (II) are presented. Two methods were based on charge transfer complexation reaction of these drugs, where they act as n-donors, with either pi acceptor 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) and with sigma acceptor as iodine. A third method was also investigated depending on ternary complex formation with eosin and copper (II). The colored products were quantified spectrophotometrically using absorption bands at 457 nm for DDQ (method A) at 293 and 359 nm for iodine (method B) and at 549 nm using ternary complex formation (method C), for both drugs. The molar combining ratio and the optimum assay conditions were studied. These methods determined the lansoprazole in concentration ranges from 10 to 90, 1.48 to 6.65 and 3.69 to 16.61 microg ml(-1) with mean percentage recovery 99.63% for DDQ, 99.71%, 99.18% for iodine and 99.76% for ternary complex and with relative standard deviation 0.11, 0.24, 0.13 and 0.36%, respectively. For pantoprazole, the concentration ranges were 10-60, 17.7-141.6 and 4.3-25.9 microg ml(-1) with mean percentage recovery 99.51, 98.97, 99.84 and 99.46% and relative standard deviation 0.53, 1.21, 0.65, 0.81% for the three mentioned methods, respectively. Investigation of the formed complexes was made with respect to its composition, molar ratio of the reaction, association constant K(C)AD, molar absorptivity epsilon(lambda)AD and free energy change deltaG for methods (A) and (B). The proposed methods have been applied successfully to the analysis of the cited drugs either in pure form or in pharmaceutical formulations, with good accuracy and precision, compared statistically with those given by the reported methods. They are recommended for quality control and routine analysis.

PMID:
10727122
[Indexed for MEDLINE]
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