Development, validation and stability indicating new RP-HPLC method for the determination of zolpidem tartrate in pure and pharmaceutical formulations

The existing physicochemical methods are inadequate to meet the requirements; hence it is proposed to improve the existing methods and to develop new methods for the assay of Zolpidem Tartrate, in pharmaceutical dosage forms adapting different available analytical techniques like RP-HPLC with a main objective to reduce the retention time of Zolpidem Tartrate. [...]according to ICH guidelines an attempt was made to create and validate a basic simple, accurate, precise and efficient RP-HPLC technique which could be easily and conveniently adopted for routine analysis of Zolpidem Tartrate in pure form and its dosage form. To develop a suitable and robust method for the determination of Zolpidem Tartrate, different mobile phases like Potassium dihydrogen ortho phosphate-Methanol, Ammonium acetate buffer-Methanol, Ammonium acetate buffer-Acetonitrile, Methanol-Water solution in various ratios (70:30, 40:60, 50:50, 60:40 V/V) were tried at flow rate 0.8ml/min. Here, the flow rate and mobile phase composition were slightly changed to lower and higher sides of the actual values to find if the change in the peak area and retention time were within limits.