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Volume:1, Issue:1- Review Article

Method Development of Validation of Stability Indicating the Simultaneous Estimation of Bisoprolol and Hydrochlorothiazide in Combined Dosage Form by RP-HPLC Method

Yamini Bugatha *

Abstract

A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Bisoprolol and Hydrochlorothiazide was successfully achieved on a phenomenex C18, 250 X4.6, 5µm or equivalent in an isocratic mode utilizing 0.1% OPA: Acetonitrile (70:30) at a flow rate of 1.2mL/min and eluate was monitored at 272nm, with a retention time of 2.489 and 4.417 minutes for Bisoprolol and Hydrochlorothiazide respectively. The method was validated and the response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Bisoprolol and 50µg/ml to150 µg/ml for and Hydrochlorothiazide. The values of the correlation coefficient were found to0.999for Bisoprolol and 1for Hydrochlorothiazide respectively. The LOD and LOQ for Bisoprolol were found to be 0.115and 0.382 respectively. The LOD and LOQ for Hydrochlorothiazide were found to be 0.0676 and 0.2252 respectively. This method was found to be good percentage recovery for Bisoprolol and Hydrochlorothiazide were found to be 99 and 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.

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