SG Vasantharaju
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NOVEL RP-HPLC METHOD FOR THE QUANTIFICATION OF ABIRATERONE ACETATE SG Vasantharaju
Journal of Global Pharma Technology Volume 08 Issue 09: (2016) September 2016
Publisher : Journal of Global Pharma Technology

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Simple, rapid, accurate and specific RP-HPLC method has been developed for quantitative estimation ofAbiraterone acetate in bulk and tablet. Separation was attained by using Acclaim C18 column (50mm x4.6 mm, 5) at 25C and 80:20 v/v acetonitrile:ammonium acetate buffer(10mM) of pH 6.0 with flow rateof 1ml/min as mobile phase and the drug was detected at 254 nm. Analytical method was said to belinear over a range of 0.125-60 g/ml with correlation constant of 0.999. Method was appeared to beprecise, robust and rugged. LOD and LOQ were found to be 10 ng/ml and 50 ng/ml respectively and themean recovery value as 100.52%.Stability indicating capability of this method has been demonstrated byanalyzing stressed samples of drug and found labile to acidic, alkaline, oxidative, thermal and photolyticconditions. Above method was applied for the estimation in API, formulation and dissolution testing ofthe dosage form. Percentage assay of the formulation was found to be 101.66%w/w. Drug released to anextent of 85.29% at 30 minutes as per FDA published method. Thus, the analytical procedure is reliableand offers advantage in terms of speed; so could be effectively used for the routine quality controlpurpose.
Development and Validation of a Simple UV-Spectroscopic Method for the Estimate Metoprolol Tartrate in Bulk and Tablet Formulation SG Vasantharaju
Journal of Global Pharma Technology Volume 9 Issue 07
Publisher : Journal of Global Pharma Technology

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Objective: UV-Spectroscopic method was developed and validated for quantitative determination of metoprolol tartrate. Method: The absorption maxima of metoprolol tartrate were found to be 223nm by using methanol as solvent. Results: The linearity range for metoprolol tartrate was 7-22μg/ml with correlation coefficient (r2) value 0.9982. The method was said to be accurate with 100% recovery and precise, robust as the %RSD was below 2. Metolar-50 marketed formulation was considered as test and assay was carried out. Assay was found to be 98.73%. Conclusion: So, a novel, simple and sensitive method was developed for assay of metoprolol tartrate and validated according to ICH Q2R1 guidelines.Keywords: Spectroscopic, Metoprolol tartrate, Absorption maxima, Assay.