Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms

Rafael, Janice Aparecida; Jabor, José Roberto; Casagrande, Rúbia; Georgetti, Sandra R.; Borin, Maria de Fátima; Fonseca, Maria José Vieira

doi:10.1590/s1516-93322007000100012

Cited by 13 publications

(9 citation statements)

References 13 publications

(21 reference statements)

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“…Determination of mesalamine related impurities by micellar electrokinetic chromatography with an ion-pair reagent was reported 33 . Mesalamine determination in pharmaceutical dosage forms by HPLC, DPPH and nitrosation was also reported 34 .…”

Section: Introductionmentioning

confidence: 99%

Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method

Kanubhai

2010

Journal of Chemistry

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In the present study gradient reversed-phase UPLC method was developed for simultaneous determination and separation of impurities and degradation products from drug product. The chromatographic separation was performed on acquity UPLC BEH C18 column (50 mm×2.1 mm, 1.7 µm) using gradient elution. Other UPLC parameters which were optimised are flow rate, 0.7 mL/min; detection wavelength, 220 nm; column oven temperature, 40°C and injection volume 7 µL. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was validated as per International Conference on Harmonization (ICH) guideline. For all impurities and mesalamine, LOQ (limit of quantification) value was found precise with RSD (related standard daviation) of less than 2.0%. In essence, the present study provides an improved low detection limit and lower run time for evaluation of pharmaceutical quality of mesalamine delayed-release formulation. Moreover, the developed method was successfully applied for quantification of impurities and degradation products in mesalamine delayed-release formulation. The same method can also be used for determination of related substances from mesalamine drug substance.

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Section: Introductionmentioning

confidence: 99%

Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method

Kanubhai

2010

Journal of Chemistry

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“…Few visible spectrophotometric methods are found in the literature for the assay of MSL. In a method reported by Rafael et al, 10 hydrogen donating ability of MSL to 1, 1-diphenyl-2-picrylhydrazyl radicals is used as basis for its determination in pharmaceutical dosage forms. Patel et al, 27 reported three methods for the assay of MSL in tablet dosage forms with Bratton-Marshall reagent, p-dimethylaminobenzaldehyde and Gibb's reagent.…”

Section: Introductionmentioning

confidence: 99%

Simple and sensitive spectrophotometric methods for the analysis of mesalamine in bulk and tablet dosage forms

Chandra¹,

Bhogela²,

Shaik³

et al. 2011

Quím. Nova

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Recebido em 26/10/10; aceito em 30/1/11; publicado na web em 1/4/11 Three simple, sensitive, economical and reproducible spectrophotometric methods (A, B and C) are described for determination of mesalamine in pure drug as well as in tablet dosage forms. Method A is based on the reduction of tungstate and/or molybdate in Folin Ciocalteu's reagent; method B describes the reaction between the diazotized drug and α-naphthol and method C is based on the reaction of the drug with vanillin, in acidic medium. Under optimum conditions, mesalamine could be quantified in the concentration ranges, 1-30, 1-15 and 2-30 µg mL -1 by method A, B and C, respectively. All the methods have been applied to the determination of mesalamine in tablet dosage forms. Results of analysis are validated statistically.

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“…Different methods have been reported for the determination of mesalazine. These methods include: Amicellar electrokinetic chromatography with ion-pair reagent [3], high performance liquid chromatography (HPLC) methods [4][5][6], voltametry [7] and fluorometry [8]. Several spectrophotometric methods have been used for the determination of mesalazine, such as UV method [1], charge transfer complex [9], diazotization of mesalazine and coupling with N-(1naphyl) ethylene diamine [10] or resorcinol [11].…”

Section: Introductionmentioning

confidence: 99%

Spectrophotometric Determination of Mesalazine Via Arsenazo III- Cerium(III) Reaction

Al-Abdaly¹

2011

J.Edu.Sci.

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A simple and sensitive spectrophotometric method has been developed for the determination of mesalazine (5-aminosalicylic acid) in pure form and in its pharmaceutical preparation(capsule). The method is based on the oxidation-reduction reaction between mesalazine and cerium (IV) ion, then reaction of cerium(III) with arsenazo III reagent in acidic medium to produce a green-blue complex, which is stable, water soluble and has a maximum absorption at 654 nm with a molar absorptivity of 2.103×10 5 l.mol -1 .cm -1 . Beer ُ s law is obeyed in the concentration range of 0.5 to 14 µg of mesalazine in a final volume of 25 ml. The proposed method has been applied successfully for determination of mesalazine in pharmaceutical preparation (capsule).

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Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms

Abstract: Mesalamine (5-aminosalicylic acid, 5-ASA) is used because of its local effects in the treatment

Cited by 13 publications

References 13 publications

Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method

Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method

Simple and sensitive spectrophotometric methods for the analysis of mesalamine in bulk and tablet dosage forms

Spectrophotometric Determination of Mesalazine Via Arsenazo III- Cerium(III) Reaction

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Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms

Abstract: Mesalamine (5-aminosalicylic acid, 5-ASA) is used because of its local effects in the treatment

Cited by 13 publications

References 13 publications

Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method

Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method

Simple and sensitive spectrophotometric methods for the analysis of mesalamine in bulk and tablet dosage forms

Spectrophotometric Determination of Mesalazine Via Arsenazo III- Cerium(III) Reaction

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Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms