Method Development and Validation of Simultaneous Estimation of Atenolol, Amlodipine besylate and Aspirin in bulk drug and formulation by HPTLC

Abstract

A unique, easy, accurate and precise HPTLC method is demonstrated for simultaneously estimating Atenolol, Amlodipine besylate and Aspirin in bulk drug (API) and in capsule dosage forms. The three drugs were separated using precoated aluminum plates, silica gel 60 F254 was used for coating the plates. The mobile phase used for separating the three drugs was n-butanol, water and acetic acid in the ratio of 8: 2: 0.2 v/v/v. The separated bands were evaluated at 235 nm. RF values for the three drugs were 0.23 ± 0.02, 0.47 ± 0.02 and 0.70 ± 0.02 for Atenolol, Amlodipine besylate and Aspirin, respectively. All the three drugs were very well resolved from each other depicting resolution of more than 2. Linearity was performed in the concentration range of 100-600 ng/spot for Atenolol, Amlodipine besylate and Aspirin, and a good linear curve was displayed over the concentration vs area plot. The limit of detection (LOD) was 80 ng/spot and limit of quantitation (LOQ) was 100 ng/spot for Atenolol, Amlodipine besylate and Aspirin, respectively. HPTLC method was successfully applied to capsule dosage form and no interference from excipients was observed. The developed method was validated as per ICH guideline and was found to be specific, precise, robust and accurate. Hence this method can be useful for routine analysis of Atenolol, Amlodipine besylate and Aspirin in pure drug and capsule forms.