alexa Abstract | Development of stability indicating RP-HPLC method and validation for the estimation of zolpidem tartrate

Journal of Chemical and Pharmaceutical Research
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Abstract

An accurate, precise, rapid and economical RP-HPLC method has been developed for the estimation of Zolpidem tartrate as per ICH guideline in pharmaceutical dosage from use ultra violet (UV) detector. Elution was carried out using a mobile phase consisting of Methanol, Acetonitrile and Ammonium acetate buffer of which pH was adjusted at 7.4 in a ratio (40:40:20v/v) and flow rate was set on 1ml/min at 254 nm, retention time for Zolpidem tartrate was found to be 5.178 min. The method was found to be linear in the concentration range of 07-13 ug/ml, in the linearity study regression equation was found to be y = 23111.46x and correlation coefficient was found to be 0.9997. This method was Rugged and Robust in different testing criteria, LOD and LOQ was found to be 0.02 μg / ml and 0.05 μg / ml respectively. Accuracy study was done in three different concentration level i.e 70, 100, 130% and % recovery of the method was found to be 99.97%, 100.02%, 100.02% respectively in 3 different levels and mean recovery was 100.00%, so method was accurate. Results of all validation parameter were within the limit as per ICH guideline.

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Author(s): Prabhat Dessai and Manasi Prabhu Dessai

Keywords

Zolpidem tartrate (ZOL), RP-HPLC, Method Development, Validation, Stability Indicating, ICH guidelines, RP-HPLC

 
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