A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium
The present paper describes the development of a reverse phase chromatographic (RPLC) method for montelukast sodium in the presence of its impurities and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, ph...
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| Format: | Article |
| Language: | English |
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Wiley
2010-01-01
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| Series: | E-Journal of Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2010/156593 |
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| author | N. Rashmitha T. Joseph Sunder Raj Ch. Srinivas N. Srinivas U. K. Ray Hemant Kumar Sharma K. Mukkanti |
| author_facet | N. Rashmitha T. Joseph Sunder Raj Ch. Srinivas N. Srinivas U. K. Ray Hemant Kumar Sharma K. Mukkanti |
| author_sort | N. Rashmitha |
| collection | DOAJ |
| description | The present paper describes the development of a reverse phase chromatographic (RPLC) method for montelukast sodium in the presence of its impurities and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of montelukast sodium was observed under acid and oxidative environment. The drug was found to be stable in other stress conditions studied. Successful separation of the drug from the process impurities and degradation products formed under stress conditions were achieved on an Atlantis dC18 (250 x 4.6 mm) 5 μm column. The gradient LC method employs solution A and solution B as mobile phase. The solution A contains aqueous 0.1% OPA and solution B contains a mixture of water, acetonitrile (5:95 v/v). The HPLC method was developed and validated with respect to linearity, accuracy, precision, specificity and ruggedness. |
| format | Article |
| id | doaj-art-50456bcac1774f5ab91c384a0a5be1c2 |
| institution | Kabale University |
| issn | 0973-4945 2090-9810 |
| language | English |
| publishDate | 2010-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | E-Journal of Chemistry |
| spelling | doaj-art-50456bcac1774f5ab91c384a0a5be1c22025-08-20T03:36:15ZengWileyE-Journal of Chemistry0973-49452090-98102010-01-017255556310.1155/2010/156593A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast SodiumN. Rashmitha0T. Joseph Sunder Raj1Ch. Srinivas2N. Srinivas3U. K. Ray4Hemant Kumar Sharma5K. Mukkanti6Department of Analytical Research, APL Research Centre (A Division of Aurobindo Pharma Ltd.), 313, Bachupally, Quthubullapur, Hyderabad-500090, IndiaDepartment of Analytical Research, APL Research Centre (A Division of Aurobindo Pharma Ltd.), 313, Bachupally, Quthubullapur, Hyderabad-500090, IndiaDepartment of Analytical Research, APL Research Centre (A Division of Aurobindo Pharma Ltd.), 313, Bachupally, Quthubullapur, Hyderabad-500090, IndiaDepartment of Analytical Research, APL Research Centre (A Division of Aurobindo Pharma Ltd.), 313, Bachupally, Quthubullapur, Hyderabad-500090, IndiaDepartment of Analytical Research, APL Research Centre (A Division of Aurobindo Pharma Ltd.), 313, Bachupally, Quthubullapur, Hyderabad-500090, IndiaDepartment of Analytical Research, APL Research Centre (A Division of Aurobindo Pharma Ltd.), 313, Bachupally, Quthubullapur, Hyderabad-500090, IndiaCentre for Pharmaceutical Science, Institute of Science and Technology, J. N. T. University, Hyderabad-500072, IndiaThe present paper describes the development of a reverse phase chromatographic (RPLC) method for montelukast sodium in the presence of its impurities and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of montelukast sodium was observed under acid and oxidative environment. The drug was found to be stable in other stress conditions studied. Successful separation of the drug from the process impurities and degradation products formed under stress conditions were achieved on an Atlantis dC18 (250 x 4.6 mm) 5 μm column. The gradient LC method employs solution A and solution B as mobile phase. The solution A contains aqueous 0.1% OPA and solution B contains a mixture of water, acetonitrile (5:95 v/v). The HPLC method was developed and validated with respect to linearity, accuracy, precision, specificity and ruggedness.http://dx.doi.org/10.1155/2010/156593 |
| spellingShingle | N. Rashmitha T. Joseph Sunder Raj Ch. Srinivas N. Srinivas U. K. Ray Hemant Kumar Sharma K. Mukkanti A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium E-Journal of Chemistry |
| title | A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium |
| title_full | A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium |
| title_fullStr | A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium |
| title_full_unstemmed | A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium |
| title_short | A Validated RP-HPLC Method for theDetermination of Impurities in Montelukast Sodium |
| title_sort | validated rp hplc method for thedetermination of impurities in montelukast sodium |
| url | http://dx.doi.org/10.1155/2010/156593 |
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