Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method
In the present study gradient reversed-phase UPLC method was developed for simultaneous determination and separation of impurities and degradation products from drug product. The chromatographic separation was performed on acquity UPLC BEH C18 column (50 mm×2.1 mm, 1.7 µm) using gradient elution. O...
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doaj-b2660fa3f696410c92a8f8d6e028a2262020-11-25T01:05:33ZengHindawi LimitedE-Journal of Chemistry0973-49452090-98102011-01-018113114810.1155/2011/382137Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC MethodTrivedi Rakshit Kanubhai0Patel Mukesh C1Kharkar Amit R2Analytical Research and Development , Integrated Product Development, Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad-500 072, IndiaP.S. Science and H.D. Patel Arts College, S.V. Campus, Kadi-382 715, Gujarat, IndiaAnalytical Research and Development , Integrated Product Development, Dr. Reddy’s Laboratories Ltd. Bachupally, Hyderabad-500 072, IndiaIn the present study gradient reversed-phase UPLC method was developed for simultaneous determination and separation of impurities and degradation products from drug product. The chromatographic separation was performed on acquity UPLC BEH C18 column (50 mm×2.1 mm, 1.7 µm) using gradient elution. Other UPLC parameters which were optimised are flow rate, 0.7 mL/min; detection wavelength, 220 nm; column oven temperature, 40 °C and injection volume 7 µL. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was validated as per International Conference on Harmonization (ICH) guideline. For all impurities and mesalamine, LOQ (limit of quantification) value was found precise with RSD (related standard daviation) of less than 2.0%. In essence, the present study provides an improved low detection limit and lower run time for evaluation of pharmaceutical quality of mesalamine delayed-release formulation. Moreover, the developed method was successfully applied for quantification of impurities and degradation products in mesalamine delayed-release formulation. The same method can also be used for determination of related substances from mesalamine drug substance.http://dx.doi.org/10.1155/2011/382137 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Trivedi Rakshit Kanubhai Patel Mukesh C Kharkar Amit R |
spellingShingle |
Trivedi Rakshit Kanubhai Patel Mukesh C Kharkar Amit R Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method E-Journal of Chemistry |
author_facet |
Trivedi Rakshit Kanubhai Patel Mukesh C Kharkar Amit R |
author_sort |
Trivedi Rakshit Kanubhai |
title |
Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method |
title_short |
Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method |
title_full |
Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method |
title_fullStr |
Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method |
title_full_unstemmed |
Determination of Mesalamine Related Impurities from Drug Product by Reversed Phase Validated UPLC Method |
title_sort |
determination of mesalamine related impurities from drug product by reversed phase validated uplc method |
publisher |
Hindawi Limited |
series |
E-Journal of Chemistry |
issn |
0973-4945 2090-9810 |
publishDate |
2011-01-01 |
description |
In the present study gradient reversed-phase UPLC method was developed for simultaneous determination and separation of impurities and degradation products from drug product. The chromatographic separation was performed on acquity UPLC BEH C18 column (50 mm×2.1 mm, 1.7 µm) using gradient elution. Other UPLC parameters which were optimised are flow rate, 0.7 mL/min; detection wavelength, 220 nm; column oven temperature, 40 °C and injection volume 7 µL. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. The method was validated as per International Conference on Harmonization (ICH) guideline. For all impurities and mesalamine, LOQ (limit of quantification) value was found precise with RSD (related standard daviation) of less than 2.0%. In essence, the present study provides an improved low detection limit and lower run time for evaluation of pharmaceutical quality of mesalamine delayed-release formulation. Moreover, the developed method was successfully applied for quantification of impurities and degradation products in mesalamine delayed-release formulation. The same method can also be used for determination of related substances from mesalamine drug substance. |
url |
http://dx.doi.org/10.1155/2011/382137 |
work_keys_str_mv |
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