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Abstract

METHOD DEVELOPMENT AND VALIDATION OF SOME ANTIHYPERTENSIVE DRUGS WITH HYDROCHLOROTHIAZIDE BY RP-HPLC

Mohini A. Patel*, Dr. Pranav Pandya, Dr. Suresh Chanda Ameta, Dr. Mayank Mehta, Dr. Seema Kothari

Abstract

A simple, reliable, specific, accurate and precise reverse phase high performance liquid chromatography method was developed and validated for simultaneous estimation of atenolol, metoprolol, propranolol with hydrochlorothiazide in pharmaceutical dosage form. Chromatographic separation was carried out on Agilent HPLC 1200 series bridge C18 column (Xbridge C18, size: 250 mm x 4.60 mm, particle size 5 μm) with a mobile phase (0.1% formic acid in water and acetonitrile) with gradient mode of a flow rate of 1 mL/min. The detection was monitored at 228 nm. The method was found applicable in the concentration range of 10 to 90%. The proposed Method was successfully applied for quantitative determination of atenolol, metoprolol, propranolol with hydrochlorothiazide in dosage form. The retention times of Atenolol, metoprolol, propranolol and hydrochlorothiazide were found to be 7.230,6.477,4.123 and 1.368min respectively theoretical plate count as per ICH limits. The limit of detection is achieved on a lowest level for making a sensitive and robust method for simultaneous and assay analysis. The Rp-HPLC method was validated and was successfully employed for the analysis of pharmaceutical formulations containing Atenolol, metoprolol, propranolol and Hydrochlorothiazide in combined tablet dosage form.

Keywords: Antihypertensive atenolol, metoprolol, propranolol, hydrochlorothiazide; RPHPLC; Method development & validation.


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