Amlodipine Besylate In Dosage Form Research Articles

Development of Colorimetric Method for the Quantitative Analysis of Amlodipine Besylate in Dosage form Using 4- Dimethyleaminobenzaldehyde as Derivatizing Reagent

The study is based on the determination of amlodipine besylate (AB) after derivatization with 4-dimethylaminobenzaldehyde (DMAB) using UV/Visible spectrophotometer at pH 5 to yield derivative that is measured at λ max 399 nm. The calibration graph obtained was liner and fulfilled Beer Lambert’s law in the concentration range 05-25 μg/mL of (AB) and DMAB having coefficient of determination R² 0.9988 with RSD 0.93% and molar absorptivity 4.04x103 mole-1 cm-1. Quantitative / analytical parameters such as pH, heating time, temperature were optimized. Reagent concentration /volume, interday and intraday studies were also carried out. There was no effect of various solvents and additives observed on the determination of AB in commercially available drugs. The method is stable, accurate, rapid and simple for the study of imine derivative of AB.

Stability Indicating RP-HPLC Method For Simultaneous Estimation of Ramipril and Amlodipine Besylate in Pharmaceutical Dosage Form

A simple and accurate stability indicating RP-HPLC method for the simultaneous estimation of Ramipril and amlodipine besylate in pharmaceutical dosage form was developed and validated. The separation of selected drugs was done by using, X-Bridge C18 (150 x 4.6 mm, 5μ) column as stationary phase and a mixture of 5 mM Ammonium acetate(45): ACN(55): 0.1%formic acid(0.5) as mobile phase. Flow rate of mobile phase was maintained at 1 ml/min at ambient temperature throughout the experiment. Quantification was achieved with ultraviolet (DAD) detection at 240 nm. The retention times of Ramipril and amlodipine besylate were found as 5.653minutes and 6.944 minutes respectively. The detector response was linear in the concentration range of 4–12μg/ml for both drugs and the regression coefficients found as 0.9999 and 0.9998 for Ramipril and amlodipine respectively. This method was found free of any interference from any excipients. The percentage recovery values for Ramipril and amlodipine was found to be in the range of 98.83–101.09% and 98.40–100.13%. The Ramipril and amlodipine subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Ramipril and amlodipine besylate were more sensitive towards alkali and oxidative degradation. The developed method has been optimized and validated according to ICH guidelines and shown to be Specific, Sensitive, Precise, Accurate, Rugged and Robust. Hence, this method can be applied for routine quality control of Ramipril and amlodipine besylate in dosage forms as well as in bulk drug.