Velmurugan, G (2010) Development and Validation of RP-HPLC Method and Uv -Spectrophotometric Simultaneous Equation Method of Bambuterol Hydrochloride and Montelukast Sodium in Combined Dosage Form. Masters thesis, College of Pharmacy, Madurai Medical College, Madurai.
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Abstract
The combination of an Anti-asthmatic drugs Montelukast Sodium and Bambuterol HCl are selected for analysis by UV spectrophotometric method and reverse phase high performance liquid chromatography. It is estimated by simultaneous equation method as the λmax of the drugs are dissimilar and their absorbance ratio lies outside the range 0.1 to 2. The next objective is to develop and validate a reverse phase high performance liquid chromatography which would be simple, rapid, efficient and reliable for the analysis of both the drugs in combined dosage form. UV spectrophotometry by simultaneous equation method and reverse phase high performance liquid chromatography were developed for analysing Montelukast sodium and Bambuterol HCl in combined tablet dosage form. For UV spectrophotometry linearity was obtained in the concentration range of 4 to 32 μg/ml for Montelukast sodium and 4 to 28 μg/ml for Bambuterol HCl. In quantitative determination the % Drug content was found to be 101.1% and 99.5% for Montelukast sodium and Bambuterol HCl respectively. Recovery experiments were performed and it was within 98 – 102%, the percentage relative standard deviation were found to be <2% which shows high precision and accuracy of the method. In HPLC method, HPLC conditions were optimized to obtain an adequate separation of eluted compounds. Initially various mobile phase were tried, to separate drugs. Mobile phase and flow rate selection was based on peak parameters (height, tailing, theoretical plates, etc). The system with buffer (Potassium hydrogen phosphate pH6): Acetonitrile : methanol (60:40v/v) with 2 ml/min flow rate is quite robust. The optimum wavelength for detection was 230nm at which better detector response for drugs was obtained. The average retention times for 4.28 min for Bambuterol HCl ,7.4 min for Montelukast sodium respectively. According to USP system suitability test are an integral part of chromatographic method. They are used to verify the reproducibility of the chromatographic system.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | RP-HPLC Method; Uv -Spectrophotometri;Bambuterol Hydrochloride; Montelukast Sodium; Combined Dosage Form |
| Subjects: | PHARMACY > Pharmaceutical Chemistry |
| Depositing User: | Ravindran C |
| Date Deposited: | 17 Aug 2017 10:14 |
| Last Modified: | 17 Aug 2017 10:14 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/2679 |
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