QUANTITATIVE METHOD DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR THE ESTIMATION OF PERINDOPRIL ERBUMINE IN PHARMACEUTICAL DOSAGE FORM
Kalyani Bhongade*, Shailesh Jawarkar and Jagruti Dolas
ABSTRACT
A new rapid, precise and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of Perindopril erbumine in bulk and pharmaceutical dosage form. The Perindopril erbumine was estimated on an isocratic method, C18 column, utilizing a mobile phase composition of acetonitrile: water: 70% perchloric acid (45:55:2), v/v, pH 5.0) at a flow rate of 1.0 mL/min with UV detection at 216 nm. The retention time of Perindopril erbumine was 5.08 min respectively. The developed method was validated for specificity, linearity, precision, accuracy, robustness as per ICH guidelines. Linearity for Perindopril erbumine was found in the range of 30.6854 μg/ml. The percentage recoveries for Perindopril erbumine ranged from 98.0-102.0 %. All the parameters were found to be within limits, which indicate that the above method was accurate and precise. Hence, it was concluded that the developed method is suitable for routine analysis of perindopril erbumine due to its less analysis time in the bulk and pharmaceutical dosage forms.
Keywords: Perindopril erbumine, Estimation, RP-HPLC, Validation, Method development.
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