scholarly journals Development and Validation of a Stability-Indicating Capillary Electrophoresis Method for the Determination of Zolpidem Tartrate in Tablet Dosage form with Positive Confirmation Using 2D and 3D-DAD Fingerprints

2014 ◽  
Vol 82 (2) ◽  
pp. 341-356
Author(s):  
Khaldun M. Al Azzam
2014 ◽  
Vol 3 (7) ◽  
pp. 296-300 ◽  
Author(s):  
Paramasivam Balan ◽  
Nagappan Kannappan

A stability indicating RP-UPLC method was developed and validated for the simultaneous determination of Thiocolchicoside (TCC) and Aceclofenac (ACF) in tablet dosage form. The chromatographic separation was carried out by Thermo Scientific UPLC Instrument, Accela 1250 Pump, auto sampler with PDA detector, using column Thermo Scientific hypersil gold C18, (50 x 2.1mm) particle size 1.9µm using 5% ammonium acetate buffer and methanol in the ratio of 40:60, pH was adjusted to 5 with ortho phosphoric acid as mobile phase at a flow rate of 250 µl/min with the detection at 276nm. The run times of the TCC and ACF were about 0.697 and 1.125 minutes, respectively. The detector response is linear from 4.8 µg/ml to 7.2 µg/ml and 63.8 µg/ml to 96 µg/ml concentrations for TCC and ACF respectively. The linear regression equation was found to be y = 20620x-677.68 (r2 = 0.9996) for TCC and y= 50931x-319.3 (r2 = 0.9997) for ACF. The detection limit and quantification limit was 0.076µg and 0.23µg for TCC and 0.27µg and 0.71µg for ACF. The percentage of assay of TCC and ACF were about 99.50% and 99.96% respectively. The stability indicating capability was established by forced degradation experiments. The method was satisfactorily validated as per the ICH guidelines.DOI: http://dx.doi.org/10.3329/icpj.v3i7.19078 International Current Pharmaceutical Journal, June 2014, 3(7): 296-300


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