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Development and Validation of a Rapid Stability-Indicating HPLC Method for Determination of Carbamazepine in Pure and Dosage Forms

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1TitleTitle of DocumentDevelopment and Validation of a Rapid Stability-Indicating HPLC Method for Determination of Carbamazepine in Pure and Dosage Forms
2CreatorAuthor's name, affiliation, country RAGAA EL SHEIKH, AYMAN A GOUDA*, WAFAA S. HASSAN, HESHAM HASHEM, MOHAMMED ALI and NASSER F. KANDIEL
Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt
Makkah Community College, Umm Al-Qura University, Makkah, Saudi Arabia
3SubjectDicipline(s) Chemical Science
3SubjectKeywords Carbamazepine, Rapid stability indicating LC-method, C18 column, Method validation, Stress degradation, Dosage forms
4DescriptionAbstract A new, simple, rapid and accurate stability-indicating HPLC method was developed and validated for quantitative determination of carbamazepine (CBMZ) in pure and dosage forms. An isocratic HPLC method, using a C18 reversed phase column (150 mm x4.6 mm i.d., particle size 5 μm) with isocratic binary mobile phase consisting of methanol and water (70:30,V/V), was investigated to separate the drug from its stress degradation products. The flow rate was 1.5 mL min-1 at ambient temperature and photo diode array (PDA) detector was used at 285 nm for detection. The elution time of CBMZ was found to be 2.324±0.003 minutes. The developed method was validated for system suitability, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability and robustness. Stability tests were done through exposure of the analyte solution for five different stress conditions: Reflux with 1.0 mol L-1 hydrochloric acid (HCl), reflux with 1.0 mol L-1 sodium hydroxide (NaOH), reflux with 30% hydrogen peroxide (H2O2), exposure to ultra violet radiation (UV) radiation and heating. The calibration curve was found to be linear with the equationy=0.19677x-0.306, with a correlation coefficient of (R2=0.9999) over a concentration range of 2.0-24 µgmL-1. The limits of detection and quantification were 0.02 and 0.062 µgmL-1, respectively. The recovery value of this method is 99.80% and the reproducibility is with in 1.23.
5PublishersOrganizing agency, location WWW Publications, India
6Contributor Sponsor(s) -
7DateDate (YYYY-MM-DD) -
8TypeStatus & genre Peer-reviewed Article
8TypeType
9FormateFile Formate PDF
10IdentifierUniform Resource Identifier Click Here
10IdentifierDigital Object Identifier
11SourceJournal/conference title; vol., no. (Year)Chemical Science Transactions, Volume  5 , Number  (4), (2016)
12LanuguageEnglish=en en
13RelationSupp.files
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Chemical Science Transactions | Chem Sci Trans | CST | Online Chemistry Journal | Open Access
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