Jeevanandham, P (2015) Stability Indicating RP-HPLC Assay Method Development and Validation of Eletriptan Hydrobromide Tablets. Masters thesis, College of Pharmacy, Jaya College of Paramedical Sciences, Chennai.
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Abstract
AIM AND PLAN: The drug analysis plays an essential role in the development of drugs, their manufacture and the therapeutic use. Pharmaceutical industries rely upon quantitative chemical analysis to ensure that the raw materials used and final product obtained meets the required specification. The number of drug formulations and drugs introduced in to the market has been increasing at an alarming rate. These drugs or formulations may be either in the new entities in the market or novel dosage forms or multi component dosage forms or partial structural modification of the existing drugs. For the present study Eletriptan Hydrobromide drug was selected. Eletriptan Hydrobromide is chemically known as Hydrochloride (R)-3-[(-1-Methyl- 2-pyrrolidin-2-yl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole,monohydrobromide. It act as an anti Migraine drug. Objective: Literature reveals that, various methods like HPLC, UPLC, HPTLC, RP-HPLC methods has been develop for the estimation of Eletriptan Hydrobromide alone and along with various dosage forms. Few stability indicating RP-HPLC methods were reported for estimation of Eletriptan Hydrobromide. But stability indicating assay method for determination of Eletriptan Hydrobromide was not available. So, the main objective of work is, to develop new stability indicating assay method for determination of drug Eletriptan Hydrobromide by using RP-HPLC. Specific aim: To achieve the above objective the study was carried out in following steps: To develop a simple, selective, sensitive, specific, precise stability indicating assay method by using reverse phase liquid chromatography. SUMMARY AND CONCLUSION: The active pharmaceutical agent Eletriptan Hydrobromide was selected for present work, which was act as essential therapeutic agent in the treatment of migraine head ache. Even though various analytical techniques in estimation and quantification of Eletriptan Hydrobromide, HPLC method is an emerging technique reliable in vast areas of research. Stability indicating RP-HPLC assay method for the estimation of Eletriptan Hydrobromide in marketed formulation was developed in present work. The forced degradation HPLC method was developed with mobile phase composition phosphate buffer pH 7.0 and acetonitrile in the ratio 98:2 v/v as mobile phase A, acetonitrile and methanol in the ratio 80:20 v/v as mobile phase B. Mobile phase ratio A: B (55:45), flow rate of 1.0ml/min was used on Waters X-terra, RP18, 250 x 4.6 mm, 5μ (or) equivalent column. The retention time of Eletriptan Hydrobromide was found at 5.06 min. The developed method was validated for all validation parameters as per ICH guidelines. The linearity range for Ele.HBr was found 25% to 150%, with regression value of 0.9999. The %RSD values for precision studies were found below 2%. The method has been validated in assay of tablet dosage form. The method was also meets the specifications for the robustness studies. The results of validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The stability study on Eletriptan Hydrobromide tablet formulation. The method is specific and unaffected by presence of degradants from stress degradation.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | RP-HPLC ; Assay Method ; Eletriptan Hydrobromide Tablets |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 20 Dec 2017 11:02 |
| Last Modified: | 20 Dec 2017 12:06 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/4587 |
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