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2011•Research Journal of Pharmacy and TechnologyRequires access

A Validated Method for Development of Darifenacin Hydrobromide asActive Pharmaceutical Ingredient and Tablet Dosage form by UV- Spectroscopy

S. Kathirvel, S.V. Satyanarayana, G. Devalarao

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Abstract

The development and validation of an analytical ultraviolet (UV) spectroscopic method to quantify Darifenacin hydrobromide as a single active moiety in tablet was undertaken. The study was carried out as per USP and ICH guidelines. The proposed method was more sensitive in terms of per cent relative standard deviation (RSD), limit of detection (LOD), limit of quantification (LOQ), linearity and accuracy. Darifenacin Hydrobromide was estimated at 286.6 nm in 10%V/V 3N NaOH solution in methanol with linearity range of 10–100μg/mL, Detection limit 3.723 μg/mL, Quantification limit 11.28 μg/mL, molar absorptivity 4.116 X 103 L/mol/cm and correlation coefficient 0.9988. The recovery studies confirmed the accuracy of the method.

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What this paper is about

The development and validation of an analytical ultraviolet (UV) spectroscopic method to quantify Darifenacin hydrobromide as a single active moiety in tablet was undertaken. The study was carried out as per USP and ICH guidelines. The proposed method was more sensitive in terms of per cent relative standard deviation (RSD), limit of detection (LOD), limit of quantification (LOQ), linearity and accuracy. Darifenacin Hydrobromide was estimated at 286.6 nm in 10%V/V 3N NaOH solution in methanol with linearity range of 10–100μg/mL, Detection limit 3.723 μg/mL, Quantification limit 11.28 μg/mL, molar absorptivity 4.116 X 103 L/mol/cm and correlation coefficient 0.9988. The recovery studies confirmed the accuracy of the method.

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Available abstract

The development and validation of an analytical ultraviolet (UV) spectroscopic method to quantify Darifenacin hydrobromide as a single active moiety in tablet was undertaken. The study was carried out as per USP and ICH guidelines. The proposed method was more sensitive in terms of per cent relative standard deviation (RSD), limit of detection (LOD), limit of quantification (LOQ), linearity and accuracy. Darifenacin Hydrobromide was estimated at 286.6 nm in 10%V/V 3N NaOH solution in methanol with linearity range of 10–100μg/mL, Detection limit 3.723 μg/mL, Quantification limit 11.28 μg/mL, molar absorptivity 4.116 X 103 L/mol/cm and correlation coefficient 0.9988. The recovery studies confirmed the accuracy of the method.

Key concepts: Detection limit, Molar absorptivity, Dosage form, Correlation coefficient, Ultraviolet visible spectroscopy, Chromatography, Chemistry, Relative standard deviation

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A Validated Method for Development of Darifenacin Hydrobromide asActive Pharmaceutical Ingredient and Tablet Dosage form by UV- Spectroscopy — Research Paper | ScholarLens