Quantitative Determination of Amlodipine Besylate without Derivatized in Pure Form and Tablet Dosage Forms with UV Spectrophotometric Method

Abstract

The present work describes the development and validation of UV Spectrophotometric method for direct determination of underivatized amlodipine besylate (ADB) in pure and tablet dosage forms. The validation parameters of linearity, precision, accuracy, recovery, specificity, limit of detection and limit of quantification were studied. The range of quantification for proposed method was 2-17 µg/mL. The precision of method was calculated as the relative standard deviation (RSD) and less than 2 %, and accuracy (relative error) was better than 6 % (n = 6). The developed method was successfully applied for the assay of pharmaceutical dosage forms which do not require any preliminary separation or treatment of the samples. The RSD values for Norlopin® tablet (5 mg) and Norvasc® tablet (5 mg) was found to be less than 2 %. The results obtained from this method were compared with two reference method reported in literature and no significant difference was found statistically (p>0.05).

Keywords

• Amlodipine besylate
• tablets
• UV spectrophotometric method

Kaynakça

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