Abstract
A Simple, Precise, Stability indicating reverse phase HPLC method has been developed and validated in order to determine Doxazosin mesylate uncoated tablet dosage form. A Chromolith RP-18 column made up of Stainless Steel has been used with dimensions 100mm x 4.6mm x 10m. An Isocratic method with Mobile phase consisting of phosphate buffer: Methanol (40:60) ratio. A UV-Detector is used and the wavelength was set at 251nm.At the flow rate of 1.0ml/min the mobile phase was run for 10 minutes. The method was validated for Linearity, Precision, Accuracy, Robustness, and Stability of analytical solution. The Linearity range for the standard and the placebo was found to be between 50% and 150%. The method was validated for precision in method, system and intermediate. All the validation parameters have come under the limits.
Highlights
Doxazosin Mesylate is a quinazoline compound that is a selective inhibitor of the alpha[1] subtype of alphaadrenergic receptors
3.1 Specificity / Selectivity: Selectivity was performed by injecting the diluent blank solution, excipient blend, system suitability solution, test solution
3.1.1 Acceptance criteria: The Doxazosin mesylate peak should be well resolved from any other peak and from each other
Summary
Doxazosin Mesylate is a quinazoline compound that is a selective inhibitor of the alpha[1] subtype of alphaadrenergic receptors. Doxazosin mesylate (4 amino-2-[4-(1, 4-benzodiaxan-2-carbonyl)-piperazine-1-yl]-6,7-methoxy quinazoline mesylate, a quinazoline derivative, is effective and well known for treatment of hypertension and benign prostatic hyperplasia by selectively blocking α-1 adreno receptor[1,2]. Several methods have been reported for the determination of Doxazosin in plasma and pharmaceutical formulations including HPLC, LC-MS, UV spectrophotometry and HPTLC3,4,5,6
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