Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets
The purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify in vitro dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form. Method development was performed on C 18, 100×4.6 mm ID, and 10 μm pa...
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| Format: | Article |
| Language: | English |
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Wiley
2013-01-01
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| Series: | Journal of Analytical Methods in Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2013/976034 |
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| author | Md. Saddam Nawaz |
| author_facet | Md. Saddam Nawaz |
| author_sort | Md. Saddam Nawaz |
| collection | DOAJ |
| description | The purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify in vitro dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form. Method development was performed on C 18, 100×4.6 mm ID, and 10 μm particle size column, and injection volume was 20 μL using a diode array detector (DAD) to monitor the detection at 280 nm. The mobile phase consisted of buffer: acetonitrile at a ratio of 60 : 40 (v/v), and the flow rate was maintained at 1.0 mL/min. The method was validated in terms of suitability, linearity, specificity, accuracy, precision, stability, and sensitivity. Linearity was observed over the range of concentration 0.05–12.0 μg/mL, and the correlation coefficient was found excellent >0.999. The method was specific with respect to rabeprazole sodium, and the peak purity was found 99.99%. The method was precise and had relative standard deviations (RSD) less than 2%. Accuracy was found in the range of 99.9 to 101.9%. The method was robust in different variable conditions and reproducible. This proposed fast, reliable, cost-effective method can be used as quality control tool for the estimation of rabeprazole sodium in routine dissolution test analysis. |
| format | Article |
| id | doaj-art-3502c4d927f540f8ab2d69e1cbb24ed7 |
| institution | Kabale University |
| issn | 2090-8865 2090-8873 |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Analytical Methods in Chemistry |
| spelling | doaj-art-3502c4d927f540f8ab2d69e1cbb24ed72025-02-03T07:24:33ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732013-01-01201310.1155/2013/976034976034Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release TabletsMd. Saddam Nawaz0Quality Assurance Department, ACI Ltd., Narayanganj 1400, BangladeshThe purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify in vitro dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form. Method development was performed on C 18, 100×4.6 mm ID, and 10 μm particle size column, and injection volume was 20 μL using a diode array detector (DAD) to monitor the detection at 280 nm. The mobile phase consisted of buffer: acetonitrile at a ratio of 60 : 40 (v/v), and the flow rate was maintained at 1.0 mL/min. The method was validated in terms of suitability, linearity, specificity, accuracy, precision, stability, and sensitivity. Linearity was observed over the range of concentration 0.05–12.0 μg/mL, and the correlation coefficient was found excellent >0.999. The method was specific with respect to rabeprazole sodium, and the peak purity was found 99.99%. The method was precise and had relative standard deviations (RSD) less than 2%. Accuracy was found in the range of 99.9 to 101.9%. The method was robust in different variable conditions and reproducible. This proposed fast, reliable, cost-effective method can be used as quality control tool for the estimation of rabeprazole sodium in routine dissolution test analysis.http://dx.doi.org/10.1155/2013/976034 |
| spellingShingle | Md. Saddam Nawaz Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets Journal of Analytical Methods in Chemistry |
| title | Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets |
| title_full | Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets |
| title_fullStr | Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets |
| title_full_unstemmed | Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets |
| title_short | Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets |
| title_sort | validation and application of a new reversed phase hplc method for in vitro dissolution studies of rabeprazole sodium in delayed release tablets |
| url | http://dx.doi.org/10.1155/2013/976034 |
| work_keys_str_mv | AT mdsaddamnawaz validationandapplicationofanewreversedphasehplcmethodforinvitrodissolutionstudiesofrabeprazolesodiumindelayedreleasetablets |