Abstract

SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF AMLODIPINE IN SOLID DOSAGE FORM

Samiksha Rupesh Patil, *Yash Sanjay Bhosale, Pratiksha Harishchandra Sawant, Piyush Bakshi, Pradip Ramesh Waghmode

ABSTRACT

Amlodipine is an Anti-Hypertensive drug, which comes under the class of Calcium channel blocker derivatives. Calcium channel blockers are a group of medications that disrupt the movement of calcium through calcium channels. These drugs are used to lower blood pressure by lowering the movement of calcium into the cells of the blood vessels walls. It makes easier to pump the blood through the blood walls. As a result, the heart doesn’t have to work as hard and blood pressure lowers. The developed ultraviolet spectrophotometric method was simple, sensitive, accurate, precise and economic for the development and validation of Amlodipine in bulk and tablet dosage form. In this present study, the analytical method validation and development of Amlodipine was done using the different parameters of method validation as per International Council for Harmonisation Q2(R1) guidelines. Rectified Spirit using as a solvent and it shows the maximum wavelength at 239 nm and then performed all the parameters of analytical method validation like accuracy, linearity, range limit of detection and limit of quantitation. Amlodipine showed linearity over the range of 03-30 µg/ml. The correlation coefficient value obtained was 0.9993 with the regression equation y=0.033x + 0.007 The accuracy studies was done in spiking method and the recoveries ranging from 99.39%-99.72%.The standard deviation was 0.001581 .The limit of detection was 0.529µg/ml and limit of quantitation was 1.603µg/ml respectively. The method has shown good and consistent recoveries and is validated as per International Council for Harmonisation guidelines and can be used for routine quality control analysis of Amlodipine in dosage form.

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