Article

RP-HPLC Estimation of Risperidone in Tablet Dosage Forms.

Anand Pharmacy College, Opp. Town Hall, Shri Ramkrishna Seva Mandal Campus, Anand-388 001, India.
Indian Journal of Pharmaceutical Sciences (impact factor: 0.63). 70(4):494-7. DOI:10.4103/0250-474X.44601 pp.494-7
Source: PubMed

ABSTRACT A simple, specific, accurate, and precise reverse phase liquid chromatographic method was developed and validated for the estimation of risperidone in tablet dosage forms. A Phenomenex Gemini C-18, 5 mum column having 250x4.6 mm i.d. in isocratic mode, with mobile phase containing methanol: acetonitrile: 50 mM potassium dihydrogen orthophosphate (80:10:10 v/v) was used. The flow rate was 1.3 ml/min and effluents were monitored at 234 nm. Clozapine was used as an internal standard. The retention time of risperidone and clozapine were 2.5 min and 3.3 min, respectively. The method was validated for linearity, accuracy, precision, specificity, limit of quantification, limit of detection, robustness and stability. The limit of detection and limit of quantification for estimation of risperidone was found to be 500 ng/ml and 990 ng/ml, respectively. Recovery of risperidone was found to be in the range of 99.02-101.68%. Proposed method was successfully applied for the quantitative determination of risperidone in tablet formulations.

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    Article: Stability indicating HPLC determination of risperidone in bulk drug and pharmaceutical formulations.
    Zarna R Dedania, Ronak R Dedania, Navin R Sheth, Jigar B Patel, Bhavna Patel
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    ABSTRACT: The objective of the current study was to develop a validated stability-indicating assay method (SIAM) for risperidone after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions. The liquid chromatographic separation was achieved isocratically on a symmetry C18 column (5 μm size, 250 mm × 4.6 mm i.d.) using a mobile phase containing methanol: acetonitrile (80 : 20, v/v) at a flow rate of 1 mL/min and UV detection at 280 nm. Retention time of risperidone was found to be 3.35 ± 0.01. The method was linear over the concentration range of 10-60 μg/mL(r(2) = 0.998) with a limit of detection and quantitation of 1.79 and 5.44 μg/mL, respectively. The method has the requisite accuracy, specificity, sensitivity, and precision to assay risperidone in bulk form and pharmaceutical dosage forms. Degradation products resulting from the stress studies did not interfere with the detection of Risperidone, and the assay is thus stability indicating.
    International Journal of Analytical Chemistry 01/2011; 2011:124917.
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Keywords

acetonitrile
 
clozapine
 
detection
 
effluents
 
estimation
 
flow rate
 
internal standard
 
isocratic mode
 
mobile phase
 
Phenomenex Gemini C-18
 
precise reverse phase liquid chromatographic method
 
quantitative determination
 
retention time
 
risperidone
 
tablet dosage forms
 
tablet formulations
 
validated
 

S L Baldania