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Development and Validation of A Stability Indicating RP-HPLC Method For The Determination Of Adefovir Dipivoxil In Bulk And Tablet Dosage Form
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| Author:
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NILESH NALBALWAR, RAM S. SAKHARE, PEKAMWAR S.S.
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| Abstract:
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A simple, precise, specific, efficient and economical stability indicating RP-HPLC method was developed and validated for the determination of Adefovir divoxil in tablet dosage form. The HPLC method was carried out on a Greece C18 column (250mm x 4.6id) maintained at 250C. By using mobile phase Methanol: Pot.dihydrogen phosphate buffer pH 3 (80:20 v/v)(pH adjusted with ortho phosphoric acid), pumped at a flow rate of 1.0 mL/min. with UV detection at 263 nm. The chromatographic separation was obtained with a retention time of 3.435 min, and the method was found to be linear in the range of 60-140 µg/mL (r2 = 0.996). The specificity and stability-indicating capability of the method was proven through forced degradation studies, there is also seen that there was no interference of the excipients. The accuracy was 99.67%. The LOD and LOQ were 1.3108 and 3.972 µg/mL, respectively. Method validation demonstrated acceptable results for precision and robustness. The proposed method was applied for the analysis of tablet formulations.
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| Keyword:
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Stability, RP-HPLC, Adefovir, forced degradation, Validation.
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| EOI:
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| DOI:
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