Indexing Metadata
Development and Validation of Stability-Indicating Liquid Chromatographic Assay for Rifaximin (An Antibiotic) in Bulk and Pharmaceutical Dosage Forms |
| DUBLIN | CORE | METADATA ITEM | METADATA FOR THIS DOCUMENT |
| 1 | Title | Title of Document | Development and Validation of Stability-Indicating Liquid Chromatographic Assay for Rifaximin (An Antibiotic) in Bulk and Pharmaceutical Dosage Forms |
| 2 | Creator | Author's name, affiliation, country | M. MATHRUSRI ANNAPURNA, B. SAI PAVAN KUMAR,
B. VENKATESH and J. RAJ PRAKASH
Department of Pharmaceutical Analysis & Quality Assurance,
GITAM, Institute of Pharmacy, GITAM University, Visakhapatnam, India |
| 3 | Subject | Dicipline(s) | Chemical Science |
| 3 | Subject | Keywords | RP-HPLC, Rifaximin, Stability-indicating, Validation, ICH |
| 4 | Description | Abstract | An isocratic reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of Rifaximin. Chromatographic separation was achieved on a C18 column using an aqueous tetra butyl ammonium hydrogen sulphate (10 mM) (pH 3.37): acetonitrile (40:60, v/v), with flow rate 1.2 mL/min (UV detection at 441 nm). Linearity was observed in the concentration range of
0.1–200 μg/mL (R2 = 0.9999). The limit of quantitation was found to be 0.0794 μg/mL and the limit of detection was found to be 0.0241 μg/mL. Rifaximin was subjected to stress conditions of degradation in aqueous solutions including acidic, alkaline, oxidation, photolysis and thermal degradation. The forced degradation studies were performed by using HCl, NaOH, H2O2, thermal and UV radiation. Rifaximin is more sensitive towards acidic conditions in comparison to oxidation and very much resistant towards alkaline, thermal and photolytic degradations. The method was validated as per ICH guidelines. The method is simple, specific, precise, robust and accurate for the determination of Rifaximin in pharmaceutical formulations. |
| 5 | Publishers | Organizing agency, location | WWW Publications, India |
| 6 | Contributor | Sponsor(s) | - |
| 7 | Date | Date (YYYY-MM-DD) | - |
| 8 | Type | Status & genre | Peer-reviewed Article |
| 8 | Type | Type | |
| 9 | Formate | File Formate | PDF |
| 10 | Identifier | Uniform Resource Identifier | Click Here |
| 10 | Identifier | Digital Object Identifier | |
| 11 | Source | Journal/conference title; vol., no. (Year) | Chemical Science Transactions, Volume 3 , Number (2), (2014) |
| 12 | Lanuguage | English=en | en |
| 13 | Relation | Supp.files | |
| 14 | Coverage | | - |
| 15 | Copyright | Copyright and permissions | |
Chemical Science Transactions | Chem Sci Trans | CST | Online Chemistry Journal | Open Access
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