Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Sciences, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai-603117, Tamilnadu, India.
Objective: A simple, accurate, precise, Stability indicating new RP-HPLC method was developed and validated for Zolpidem tartrate in pure and pharmaceutical formulations. Method: The literature survey reveals that good analytical methods are not available for the drugs like Zolpidem Tartrate, which suffer from major disadvantage such as low sensitivity, lack of selectivity and simplicity. The existing physicochemical methods are inadequate to meet the requirements; hence a new RP-HPLC method has been developed for the assay of Zolpidem Tartrate in pure and pharmaceutical dosage forms. A Symmetry XTerra C18 (4.6 x 150mm, 5μm, Make: Waters) or equivalent in an isocratic mode with mobile phase Ammonium Acetate Buffer (pH 4.5): Methanol (40: 60%v/v) was used. The flow rate was 0.8 ml/min and effluent was monitored by UV/PDA detector at 300nm. The retention time of Zolpidem Tartrate was at 3.14 min. The linearity range was found to be 20–60μg/ml. The proposed method was validated statistically. Results: The method developed was approved for various parameters like accuracy, specificity, precision, range, linearity, robustness, LOD, LOQ and system suitability according to ICH guidelines. The results got were according the acceptance criteria. Conclusion: The sample recoveries in the formulation were in good agreement with their respective label claims and no interference of formulation excipients in the estimation. The technique could be easily and conveniently adopted for routine analysis of Zolpidem Tartrate in pure form and its dosage form and also for dissolution or similar studies.
Zolpidem Tartrate, RP-HPLC, Validation and Forced Degradation Studies
