Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline Impurity
A reversed phase ultra performance liquid chromatography (UPLC) method was developed and validated for the quantification of aniline in mesalamine delayed-release tablets. The optimization of the experimental condition was carried out considering some important requirements like, detection limit, sh...
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2011-01-01
|
| Series: | E-Journal of Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2011/953235 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849402818669051904 |
|---|---|
| author | Rakshit Kanubhai Trivedi Mukesh C. Patel |
| author_facet | Rakshit Kanubhai Trivedi Mukesh C. Patel |
| author_sort | Rakshit Kanubhai Trivedi |
| collection | DOAJ |
| description | A reversed phase ultra performance liquid chromatography (UPLC) method was developed and validated for the quantification of aniline in mesalamine delayed-release tablets. The optimization of the experimental condition was carried out considering some important requirements like, detection limit, short run time and reproducibility. In the present study, isocratic reversed-phase UPLC method was developed for determination and separation of aniline from the drug product. The drug and impurity are well separated by using a reversed phase (Reprosil Gold C18-XBD) column and mobile phase comprising of buffer pH 6.0 and acetonitrile in the ratio of 90:10 v/v. Other UPLC parameters which were optimised are flow rate, 0.5 mL/min; detection wavelength, 200 nm; column oven temperature, 50 °C and injection volume 7 µL. Stability indicating capability was also established by forced degradation experiments. The method was validated as per ICH guideline. LOQ (limit of quantification) concentration (18 ng/mL) was found precise with RSD of less than 2%. 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 also successfully applied for quantification of aniline in mesalamine delayed-release formulation. The same method can also be used for determination of aniline from drug substances. |
| format | Article |
| id | doaj-art-94ae296a158d4f46a9387182fa2884cd |
| institution | Kabale University |
| issn | 0973-4945 2090-9810 |
| language | English |
| publishDate | 2011-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | E-Journal of Chemistry |
| spelling | doaj-art-94ae296a158d4f46a9387182fa2884cd2025-08-20T03:37:27ZengWileyE-Journal of Chemistry0973-49452090-98102011-01-018116717910.1155/2011/953235Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline ImpurityRakshit Kanubhai Trivedi0Mukesh C. Patel1Analytical Research and Development, Integrated Product DevelopmentDr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, IndiaP.S. Science and H.D. Patel Arts CollegeS.V. Campus, Kadi-382 715, Gujarat, IndiaA reversed phase ultra performance liquid chromatography (UPLC) method was developed and validated for the quantification of aniline in mesalamine delayed-release tablets. The optimization of the experimental condition was carried out considering some important requirements like, detection limit, short run time and reproducibility. In the present study, isocratic reversed-phase UPLC method was developed for determination and separation of aniline from the drug product. The drug and impurity are well separated by using a reversed phase (Reprosil Gold C18-XBD) column and mobile phase comprising of buffer pH 6.0 and acetonitrile in the ratio of 90:10 v/v. Other UPLC parameters which were optimised are flow rate, 0.5 mL/min; detection wavelength, 200 nm; column oven temperature, 50 °C and injection volume 7 µL. Stability indicating capability was also established by forced degradation experiments. The method was validated as per ICH guideline. LOQ (limit of quantification) concentration (18 ng/mL) was found precise with RSD of less than 2%. 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 also successfully applied for quantification of aniline in mesalamine delayed-release formulation. The same method can also be used for determination of aniline from drug substances.http://dx.doi.org/10.1155/2011/953235 |
| spellingShingle | Rakshit Kanubhai Trivedi Mukesh C. Patel Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline Impurity E-Journal of Chemistry |
| title | Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline Impurity |
| title_full | Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline Impurity |
| title_fullStr | Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline Impurity |
| title_full_unstemmed | Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline Impurity |
| title_short | Evaluation of Pharmaceutical Quality of Mesalamine Delayed Release Tablets Using a New High Sensitivity Reversed-Phase UPLC Method for its Genotoxic/Aniline Impurity |
| title_sort | evaluation of pharmaceutical quality of mesalamine delayed release tablets using a new high sensitivity reversed phase uplc method for its genotoxic aniline impurity |
| url | http://dx.doi.org/10.1155/2011/953235 |
| work_keys_str_mv | AT rakshitkanubhaitrivedi evaluationofpharmaceuticalqualityofmesalaminedelayedreleasetabletsusinganewhighsensitivityreversedphaseuplcmethodforitsgenotoxicanilineimpurity AT mukeshcpatel evaluationofpharmaceuticalqualityofmesalaminedelayedreleasetabletsusinganewhighsensitivityreversedphaseuplcmethodforitsgenotoxicanilineimpurity |