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Development and Validation for Estimation of Abiraterone acetate in Bulk and Pharmaceutical Dosage Form by UPLC


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1 Department of Pharmaceutical Analysis, Joginpally B.R Pharmacy College, Yenkapally, Moinabad, R.R. Dist. Telangana, India
     

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A simple, Robust, stability indicated method was developed for the estimation of Abiraterone by RP-UPLC technique. Chromatographic conditions used are, stationary phase SB C8 100 x 3.0 mm, 1.8. Mobile phase 0.01N NaH2PO4: Acetonitrile in the ratio of 60:40v/v and flow rate were maintained at 0.3 ml/min, detection wave length was 235 nm, and column temperature was set to 30oC. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.6 for repeatability and 1.1 for intermediate precision. LOD and LOQ are 0.09μg/ml and 0.27μg/ml respectively. Degradation studies of Abiraterone were done, in all conditions and it is within the acceptable range.

Keywords

UPLC, Abiraterone Acetate, Mobile Phase, Method Development.
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  • Development and Validation for Estimation of Abiraterone acetate in Bulk and Pharmaceutical Dosage Form by UPLC

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Authors

V. Mohan Goud
Department of Pharmaceutical Analysis, Joginpally B.R Pharmacy College, Yenkapally, Moinabad, R.R. Dist. Telangana, India
B. Sandhya Rani
Department of Pharmaceutical Analysis, Joginpally B.R Pharmacy College, Yenkapally, Moinabad, R.R. Dist. Telangana, India
J. V. C. Sharma
Department of Pharmaceutical Analysis, Joginpally B.R Pharmacy College, Yenkapally, Moinabad, R.R. Dist. Telangana, India
P. Sirisha
Department of Pharmaceutical Analysis, Joginpally B.R Pharmacy College, Yenkapally, Moinabad, R.R. Dist. Telangana, India

Abstract


A simple, Robust, stability indicated method was developed for the estimation of Abiraterone by RP-UPLC technique. Chromatographic conditions used are, stationary phase SB C8 100 x 3.0 mm, 1.8. Mobile phase 0.01N NaH2PO4: Acetonitrile in the ratio of 60:40v/v and flow rate were maintained at 0.3 ml/min, detection wave length was 235 nm, and column temperature was set to 30oC. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.6 for repeatability and 1.1 for intermediate precision. LOD and LOQ are 0.09μg/ml and 0.27μg/ml respectively. Degradation studies of Abiraterone were done, in all conditions and it is within the acceptable range.

Keywords


UPLC, Abiraterone Acetate, Mobile Phase, Method Development.

References