Spectroscopic determination of PDAC induced coupling reaction and stability indicating stress degradation studies of zolpidem in bulk and pharmaceutical formulation

A simple and sensitive spectrophotometric method was developed for the determination of Zolpidem either in API or in pharmaceutical formulations. The method is based on reaction of Zolpidem with paradimethyl aminocinnamaldehyde (PDAC) resulting in the complex formation of orange yellow colored chromogen having absorption maxima at 436 nm. Beer's law is obeyed in the concentration range of 1-5 μg/ml. The proposed method was successfully validated as per the ICH guidelines for API and pharmaceutical preparations of Zolpidem. The percentage recovery studies were performed and the percentage recovery was found to be of 99.38-100.48%, the system was found to be linear and the correlation coefficient (r2) was found to be 0.998, method was found to be precise and the relative standard deviation was found to be 0.511, detection limit was found to 0.3 μg/ml and quantification limit was found to be 1μg/ml respectively. The stress degradation studies were also peformed for the API as per the ICH guidelines, the degradation was observed in oxidative stress and dry heat induced studies.

Author(s): Rubesh Kumar. S, Hima Sai Bindu. N, Hima. V, Subhahan Bee. D, Duganath. N, Bharath Ratna Kumar. P and Devanna. N

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