Simple, specific, accurate, precise and reproducible and robust method have been developed and validated
for the Simultaneous Estimation of Metoprolol tartrate, Amlodipine besylate and Chlorthalidone in
synthetic mixture. The Reverse Phase High Performance Liquid Chromatography, the chromatographic
system was equipped with Cosmosil C18 (250 mm × 4.6 mm, 5 ?m) and UV detector set at 222 nm, in
conjunction with a mobile phase of Phosphate Buffer pH 2.5: ACN: Methanol in the ration of
(50:30:20%v/v), at a flow rate of 1.5 mL/min. Retention time was noted to be 1.44, 1.33 and 1.13 for
Metoprolol Tartrate, Amlodipine Besylate and Chlorthalidone respectively. The various analytical
parameters, including specificity, linearity, LOD, LOQ, precision, accuracy, and robustness, were
determined ICH guidelines. The method was linear over the range of 245.53-736.60 ?g/ml, 25.06-75.18
?g/ml and 24.81-74.44 ?g/ml for Metoprolol Tartrate, Amlodipine Besylate and Chlorthalidone
respectively. The % recoveries for Metoprolol Tartrate was noted to be 101.7% - 100.5%, 98.4% - 101.3%
for Amlodipine Besylate and 100.7% - 99.8% for Chlorthalidone. The developed RP-HPLC method was
found to be specific, accurate, precise, robust for simultaneous estimation of Metoprolol Tartrate,
Amlodipine Besylate and Chlorthalidone in synthetic mixture and stable for routine
Keywords: Metoprolol tartrate, Amlodipine besylate, Chlorthalidone, RP-HPLC method, Method
Development
Publication date: 01/06/2025
https://ijbpas.com/pdf/2025/June/MS_IJBPAS_2025_9109.pdf
Download PDF
https://doi.org/10.31032/IJBPAS/2025/14.6.9109
