Abstract

METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC FOR ESTIMATION OF ZOLPIDEM TARTARATE

N. Ramalakshmi*, C. N. Nalini, S. Sivaguru, A. Teja and S. Arun Kumar

ABSTRACT

The objective is to develop and validate a new simple, rapid and sensitive isocratic RP-HPLC method for the determination of Zolpidem tartarate. The method employs Waters Alliance HPLC system on Novapak C18 (3.9 x 150 mm, 4.0 m) column. Best chromatographic separation was achieved by using buffer, Acetonitrile and methanol (59:18:23) as mobile phase with a flow rate of 1.5ml/min and isocratic elution with a total run time of 10 minutes. Detection of the compound was carried out at 254nm. The retention time of Zolpidem tartarate was found to be 6.095. The linearity studies ranges from at the concentration range of 50 -150 μg/ml and this method was validated for accuracy, precision, linearity, ruggedness and robustness as per ICH guidelines. The present newly developed method was found to be accurate, precise and can be useful for routine Quality control analysis.

Keywords: Zolpidem tartarate, RP-HPLC, ICH, Analytical method validation.