Asian Journal of Research in Chemistry

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Validated Stability-Indicating HPLC Method for the Determination of Pantoprazole in the Presence of its Degradation Products


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1 Department of Medicinal Chemistry, University of Medical Sciences, Tehran-14155-6451, Iran, Islamic Republic of
     

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Pantoprazole is a gastric proton pump inhibitor which is used for treatment of gastric and duodenal ulcers. In this report the stress degradation of pantoprazole was studied and an HPLC method was developed for the determination of pantoprazole in the presence of its degradation products. Pantoprazole was relatively stable in basic conditions but unstable under acidic condition, oxidative condition, heat, and light. Separation of pantoprazole and its degradation products was achieved on a Nova-Pak C18 column using a mixture of acetonitrile and KH2PO4 10 mM (pH 7.4) (25:75) as mobile phase. UV detection was performed at 290 nm. The method was linear over the range of 1-50 μg/mL pantoprazole (r2>0.999). The within-day and between-day precision values were also in the range of 0.7-3.1%. The proposed method was successfully used for the determination of pantoprazole in tablets and dissolution medium.

Keywords

Pantoprazole, HPLC, Stability-Indicating, Stress Degradation.
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  • Validated Stability-Indicating HPLC Method for the Determination of Pantoprazole in the Presence of its Degradation Products

Abstract Views: 263  |  PDF Views: 1

Authors

Effat Souri
Department of Medicinal Chemistry, University of Medical Sciences, Tehran-14155-6451, Iran, Islamic Republic of
Nazanin Shabani Ravari
Department of Medicinal Chemistry, University of Medical Sciences, Tehran-14155-6451, Iran, Islamic Republic of
Farhad Alvandifar
Department of Medicinal Chemistry, University of Medical Sciences, Tehran-14155-6451, Iran, Islamic Republic of
Arsalan Negahban Aghdami
Department of Medicinal Chemistry, University of Medical Sciences, Tehran-14155-6451, Iran, Islamic Republic of
Maliheh Barazandeh Tehrani
Department of Medicinal Chemistry, University of Medical Sciences, Tehran-14155-6451, Iran, Islamic Republic of
Massoud Amanlou
Department of Medicinal Chemistry, University of Medical Sciences, Tehran-14155-6451, Iran, Islamic Republic of

Abstract


Pantoprazole is a gastric proton pump inhibitor which is used for treatment of gastric and duodenal ulcers. In this report the stress degradation of pantoprazole was studied and an HPLC method was developed for the determination of pantoprazole in the presence of its degradation products. Pantoprazole was relatively stable in basic conditions but unstable under acidic condition, oxidative condition, heat, and light. Separation of pantoprazole and its degradation products was achieved on a Nova-Pak C18 column using a mixture of acetonitrile and KH2PO4 10 mM (pH 7.4) (25:75) as mobile phase. UV detection was performed at 290 nm. The method was linear over the range of 1-50 μg/mL pantoprazole (r2>0.999). The within-day and between-day precision values were also in the range of 0.7-3.1%. The proposed method was successfully used for the determination of pantoprazole in tablets and dissolution medium.

Keywords


Pantoprazole, HPLC, Stability-Indicating, Stress Degradation.