Estimation and Validation of A Polypill Containing Amlodipine Besylate, Hydrochlorothiazide and Telmisartan by RPHPLC

Rajendra P Rathnam and Selina

Abstract

Objective: A new, simple, accurate RP-HPLC method was developed for the simultaneous estimation of drugs in a polypill containing amlodipinebesylate, hydrochlorothiazide and telmisartan by RP-HPLC. Method: Good chromatographic separation was accomplished in isocratic mode using mixed phosphate buffer: acetonitrile (55:45) as mobile phase, and Kromasil (250 mm × 4.6 mm i.d, 5 μm particle size) column as stationary phase havinga flow rate of 1.0 mL/min at detection wavelength of 254 nm. Results: The time of retention for hydrochlorothiazide, amlodipine and telmisartan was established at 3.2 min, 4.5 min and 5.7 min respectively. This method was validated as per ICH guidelines.21,22 Conclusion: This low cost method was proved to be successful when applied to pharmaceutical dosage forms without any interference in the chromatogram.

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