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A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets

A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of rosuvastatin calcium in tablets and for determination of content uniformity. An isocratic separation of rosuvastatin calcium was achieved on YMC C8, 150×4.6 mm i.d., 5 μm particle siz...

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Detalles Bibliográficos
Autores principales: Kaila, H. O., Ambasana, M. A., Thakkar, R. S., Saravaia, H. T., Shah, A. K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116304/
https://www.ncbi.nlm.nih.gov/pubmed/21694991
http://dx.doi.org/10.4103/0250-474X.78526
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author Kaila, H. O.
Ambasana, M. A.
Thakkar, R. S.
Saravaia, H. T.
Shah, A. K.
author_facet Kaila, H. O.
Ambasana, M. A.
Thakkar, R. S.
Saravaia, H. T.
Shah, A. K.
author_sort Kaila, H. O.
collection PubMed
description A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of rosuvastatin calcium in tablets and for determination of content uniformity. An isocratic separation of rosuvastatin calcium was achieved on YMC C8, 150×4.6 mm i.d., 5 μm particle size columns with a flow rate of 1.5 ml/min and using a photodiode array detector to monitor the eluate at 242 nm. The mobile phase consisted of acetonitrile: water (40:60, v/v) pH 3.5 adjusted with phosphoric acid. The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. All degradation products in an overall analytical run time of approximately 10 min with the parent compound rosuvastatin eluting at approximately 5.2 min. Response was a linear function of drug concentration in the range of 0.5-80 μg/ml (r(2)= 0.9993) with a limit of detection and quantification of 0.1 and 0.5 μg/ml respectively. Accuracy (recovery) was between 99.6 and 101.7%. Degradation products resulting from the stress studies did not interfere with the detection of rosuvastatin and the assay is thus stability-indicating.
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spelling pubmed-31163042011-06-21 A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets Kaila, H. O. Ambasana, M. A. Thakkar, R. S. Saravaia, H. T. Shah, A. K. Indian J Pharm Sci Research Paper A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of rosuvastatin calcium in tablets and for determination of content uniformity. An isocratic separation of rosuvastatin calcium was achieved on YMC C8, 150×4.6 mm i.d., 5 μm particle size columns with a flow rate of 1.5 ml/min and using a photodiode array detector to monitor the eluate at 242 nm. The mobile phase consisted of acetonitrile: water (40:60, v/v) pH 3.5 adjusted with phosphoric acid. The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. All degradation products in an overall analytical run time of approximately 10 min with the parent compound rosuvastatin eluting at approximately 5.2 min. Response was a linear function of drug concentration in the range of 0.5-80 μg/ml (r(2)= 0.9993) with a limit of detection and quantification of 0.1 and 0.5 μg/ml respectively. Accuracy (recovery) was between 99.6 and 101.7%. Degradation products resulting from the stress studies did not interfere with the detection of rosuvastatin and the assay is thus stability-indicating. Medknow Publications 2010 /pmc/articles/PMC3116304/ /pubmed/21694991 http://dx.doi.org/10.4103/0250-474X.78526 Text en Copyright: © Indian Journal of Pharmaceutical Sciences http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Paper
Kaila, H. O.
Ambasana, M. A.
Thakkar, R. S.
Saravaia, H. T.
Shah, A. K.
A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets
title A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets
title_full A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets
title_fullStr A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets
title_full_unstemmed A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets
title_short A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets
title_sort new improved rp-hplc method for assay of rosuvastatin calcium in tablets
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116304/
https://www.ncbi.nlm.nih.gov/pubmed/21694991
http://dx.doi.org/10.4103/0250-474X.78526
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