A Stability Indicating RP-HPLC Method Development and Validation for Estimation of Atenolol Amlodipine Besylate Hydrochlorothiazide in their Combined Dosage Form

B. Naresh Kumar Reddy*¹, A. Dinakar Reddy^2
1PG Research Scholar, Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Nellore, A.P.
²Professor, Department of Pharmaceutical Chemistry, Ratnam Institute of Pharmacy, Nellore, A.P.

A b s t r a c t
HPLC method generates large amount of quality data, which serve as highly powerful and convenient analytical tool. Atenolol and Amlodipine besylate was freely soluble in water and alcohol. Hydrochlorothiazide was freely soluble in alcohol and sparingly soluble in water. Methanol and potassium dihydrogen ortho phosphate (pH 3) was chosen as the mobile phase. The run time of the HPLC procedure was 10 minutes. The method was validated for system suitability, linearity, precision, accuracy, specificity, ruggedness robustness, LOD and LOQ. The system suitability parameters were within limit, hence it was concluded that the system was suitable to perform the assay. The method shows linearity between the concentration range of 10-100µg/ml. The % recovery of Atenolol, Amlodipine besylate and Hydrochlorothiazide were found to be in the range of 99.22%-100.11 %. As there was no interference due to excipients and mobile phase, the method was found to be specific. The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in Flow rate and Mobile phase composition separately and analysis being performed by different analysts. Good agreement was seen in the assay results of Pharmaceutical formulation by developed method. Hence it can be concluded that the proposed method was a good approach for obtaining reliable results and found to be suitable for the routine analysis of Atenolol, Amlodipine besylate and Hydrochlorothiazide in Bulk drug and Pharmaceutical formulation.
Keywords: Atenolol, Amlodipine besylate and Hydrochlorothiazide, HPLC

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