Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations
The objective of the current study was to develop a validated stability-indicating assay method (SIAM) for risperidone after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions. The liquid chromatographic separation was achieved isocratically...
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| Format: | Article |
| Language: | English |
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Wiley
2011-01-01
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| Series: | International Journal of Analytical Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2011/124917 |
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| author | Zarna R. Dedania Ronak R. Dedania Navin R. Sheth Jigar B. Patel Bhavna Patel |
| author_facet | Zarna R. Dedania Ronak R. Dedania Navin R. Sheth Jigar B. Patel Bhavna Patel |
| author_sort | Zarna R. Dedania |
| collection | DOAJ |
| description | The objective of the current study was to develop a validated stability-indicating assay method (SIAM) for risperidone after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions. The liquid chromatographic separation was achieved isocratically on a symmetry C18 column (5 μm size, 250 mm × 4.6 mm i.d.) using a mobile phase containing methanol: acetonitrile (80 : 20, v/v) at a flow rate of 1 mL/min and UV detection at 280 nm. Retention time of risperidone was found to be 3.35±0.01. The method was linear over the concentration range of 10–60 μg/mL(𝑟2=0.998) with a limit of detection and quantitation of 1.79 and 5.44 μg/mL, respectively. The method has the requisite accuracy, specificity, sensitivity, and precision to assay risperidone in bulk form and pharmaceutical dosage forms. Degradation products resulting from the stress studies did not interfere with the detection of Risperidone, and the assay is thus stability indicating. |
| format | Article |
| id | doaj-art-f2f4e90fa59443f2ac7f42c0344305fd |
| institution | Kabale University |
| issn | 1687-8760 1687-8779 |
| language | English |
| publishDate | 2011-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Analytical Chemistry |
| spelling | doaj-art-f2f4e90fa59443f2ac7f42c0344305fd2025-02-03T01:11:18ZengWileyInternational Journal of Analytical Chemistry1687-87601687-87792011-01-01201110.1155/2011/124917124917Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical FormulationsZarna R. Dedania0Ronak R. Dedania1Navin R. Sheth2Jigar B. Patel3Bhavna Patel4Department of Pharmaceutical Analysis, Veerayatan Institute of Pharmacy, Gujarat, Kutch, IndiaDepartment of Pharmaceutical Analysis, Veerayatan Institute of Pharmacy, Gujarat, Kutch, IndiaDepartment of Pharmaceutical Sciences, Saurashtra University, Gujarat, Rajkot, IndiaK. B. Institute of pharmaceutical Education and Research, Gandhinagar, IndiaCVM Institute for Degree Course in Pharmacy, New Vallabh Vidhyanagar, Anand, IndiaThe objective of the current study was to develop a validated stability-indicating assay method (SIAM) for risperidone after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions. The liquid chromatographic separation was achieved isocratically on a symmetry C18 column (5 μm size, 250 mm × 4.6 mm i.d.) using a mobile phase containing methanol: acetonitrile (80 : 20, v/v) at a flow rate of 1 mL/min and UV detection at 280 nm. Retention time of risperidone was found to be 3.35±0.01. The method was linear over the concentration range of 10–60 μg/mL(𝑟2=0.998) with a limit of detection and quantitation of 1.79 and 5.44 μg/mL, respectively. The method has the requisite accuracy, specificity, sensitivity, and precision to assay risperidone in bulk form and pharmaceutical dosage forms. Degradation products resulting from the stress studies did not interfere with the detection of Risperidone, and the assay is thus stability indicating.http://dx.doi.org/10.1155/2011/124917 |
| spellingShingle | Zarna R. Dedania Ronak R. Dedania Navin R. Sheth Jigar B. Patel Bhavna Patel Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations International Journal of Analytical Chemistry |
| title | Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations |
| title_full | Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations |
| title_fullStr | Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations |
| title_full_unstemmed | Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations |
| title_short | Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations |
| title_sort | stability indicating hplc determination of risperidone in bulk drug and pharmaceutical formulations |
| url | http://dx.doi.org/10.1155/2011/124917 |
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