Priya, D (2012) Method Development and Validation of Omeprazole and Cinitapride by Uv-Visible Spectrophotometry and RP-HPLC In Oral Solid Dosage Form. Masters thesis, College of Pharmacy, Madras Medical College, Chennai.
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Abstract
The present study is to develop various methods for the estimation of omeprazole and cinitapride combination in bulk and capsule dosage forms. Omeprazole is official in Indian Pharmacopoeia – 2010 and Cinitapride, a newer drug which was launched in 2007 is not official in any of the pharmacopoeias. It has been recently added in drug bank in 2012. The combination of the two drugs has been launched in 2011. A review of literature revealed that no method has been developed for the determination of omeprazole (OME) and cinitapride (CNP) in combined tablet dosage form but several methods have been reported for the estimation of omeprazole and cinitapride individually and in combination with other drugs. There is no evidence for the estimation of OME and CNP by UV-Visible spectrophotometry and RP-HPLC methods in bulk and in combined tablet dosage form. So an attempt has been made to develop simple easy to perform, accurate, cost effective and rapid spectrophotometric methods for the estimation of OME and CNP in bulk and combined oral dosage form and also to validate the developed methods. In RP-HPLC method C18 column was used for the estimation of OME and CNP. By trial and error, the mobile phase containing acetonitrile: methanol: phosphate buffer in the ratio of 40:20:40%v/v at a flow rate of 1.2mL/min was chosen. The chromatographic conditions were optimized and the effluent was monitored at 301nm for OME and at 262 for CNP. CNP showed retention time at 6.5 minutes and OME at 3.2 minutes. A calibration chart was constructed using peak area versus concentration. The assay, precision and recovery studies were performed. The results revealed that there was no interference of excipients. The %RSD values were < 1 which proved the reproducibility and specificity of the method and it can be used for routine analysis. The spectrophotometric methods developed for the estimation of OME and CNP were accurate, simple, precise, rapid and economical. All the methods have shown good precision and accuracy. The low % RSD values in recovery studies for all the above methods indicate that there is no interference due to excipients used in the formulations. Hence it is concluded that the developed UV – Visible and RP-HPLC methods could be effectively used for the routine analysis of Cinitapride and Omeprazole in pharmaceutical dosage formulation.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Omeprazole; Cinitapride; Uv-Visible Spectrophotometry; RP-HPLC;n Oral Solid Dosage Form |
| Subjects: | PHARMACY > Pharmaceutical Chemistry |
| Depositing User: | Ravindran C |
| Date Deposited: | 20 Oct 2017 06:44 |
| Last Modified: | 20 Oct 2017 06:44 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/3706 |
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