STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF ZOLPIDEM TARTRATE IN BULK AND TABLET DOSAGE FORM

Article Research, Mahajan, S Sawant
unpublished
A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) Stability indicating method has been developed for the estimation of zolpidem tartrate in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on C18 column (250X4.6mm i.d.,5μm) in isocratic mode using methanol and acetonitrile in the ratio 50:50 (v/v) as mobile phase, pumped in to the column at flow rate of 1.0 mL min −1 and the detection of eluent from the column was
more » ... from the column was carried out using variable wavelength UV detector at 293 nm. The total run time was 10 min and the column was maintained at ambient temperature. The retention time of zolpidem tartrate was 3.467 min. The standard curves were linear over the concentration range of 10-60 μg mL −1 with r 2 = 0.999 and the LOD and LOQ values for zolpidem tartrate were 0.026 μg mL −1 and 0.056 μg mL −1 , respectively. The percentage recovery was found to be 99.06 to 100.60 and the % RSD of intraday and inter day precision was found to be 0.68 and 0.61, respectively. The percentage amount of a marketed tablet formulation of zolpidem tartrate was found to be 99.08 %. Forced degradations were carried out under thermolytic, photolytic, acid and base hydrolytic and oxidative stress conditions. In the stressed sample chromatograms, it demonstrated the specificity of the assay method for their estimation in presence of degradation products. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the routine quality control analysis of zolpidem tartrate in bulk and tablet dosage forms and is stability indicating.
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