METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ANTI-HYPERTENSIVE DRUGS USING UV AND HPLC
Amit Kumar, Udit Narayan Soni, Kavita R. Loksh
ABSTRACT
This research presents the development and validation of analytical methods for the simultaneous quantification of Quinapril (QPL) and Hydrochlorothiazide (HCZ) in pharmaceutical formulations using UV spectrophotometry and RP-HPLC. The UV method involved physical characterization, melting point determination, and IR spectroscopy to confirm the identity and purity of the compounds. Solubility studies were performed to select appropriate solvents for UV analysis. Calibration curves were created by measuring absorbance at ?max of 248.0 nm for QPL and 222.0 nm for HCZ, demonstrating linearity across specified concentration ranges. The method was validated for specificity, accuracy, precision, and robustness, confirming its suitability for quality control. The RP-HPLC method optimized mobile phase composition (Acetonitrile: Methanol 50:50 v/v), column type (C18), and detection wavelength (245 nm) for effective separation of QPL and HCZ. Calibration curves showed excellent linearity (correlation coefficients > 0.999) across concentrations from 1 to 5 µg/ml. Validation studies further confirmed the method's reliability for quantifying QPL and HCZ in commercial tablet formulations. The UV method offers simplicity and cost-effectiveness for routine analysis, while RP-HPLC provides enhanced sensitivity and specificity for complex matrices. Both methods ensure accurate determination of QPL and HCZ content, supporting quality control and regulatory compliance in pharmaceutical manufacturing.
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