A validated stability-indicating HPLC assay method to investigate stability of Pantoprazole injection with injectable solutions (5 % Dextrose injection and 0.9% Sodium Chloride injection)

Binnor Anil K. (1) , Mukkanti Khagga (2) , Suryanarayana M V (3) , Roy Sunilendu B (4)
(1) Pharmaceutical Technology Center, Cadila Healthcare Ltd, Ahmedabad-382210, Gujarat, India, India ,
(2) Centre for Chemical Sciences and Technology, IST, J.N.T. University, Hyderabad-500072, Andhra Pradesh, India, India ,
(3) J.N.T. University affiliated research guide, Kukatpally, Hyderabad-500072, Andhra Pradesh, India, India ,
(4) Pharmaceutical Technology Center, Cadila Healthcare Ltd, Ahmedabad-382210, Gujarat, India, India

Abstract

Intravenous Pantoprazole is an alternative short-term treatment for patients with gastro esophageal reflux disease (GERD) who cannot take pantoprazole tablets. The stability of reconstituted solutions of Pantoprazole Injection in 5% Dextrose and 0.9% Sodium Chloride is critical before intravenous infusion, Physical stability (by pH measurement) and chemical stability (by measuring the concentration) in solution of Pantoprazole was assessed. A stability-indicating reversed phase High-Performance liquid chromatographic (HPLC) assay method was developed and validated. The reconstituted solutions were kept under storage at room temperature (25°C ±2°C) and tested as per method at 0,4,8,12,18 & 24 hours. The validation study concluded that assay method is suitable to investigate the stability of Pantoprazole injection in injectable solutions (5% Dextrose injection and 0.9% Sodium Chloride injection) and solutions are stable for up to 24 hours at 25°C.

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Authors

Binnor Anil K.
akbinnor@rediffmail.com (Primary Contact)
Mukkanti Khagga
Suryanarayana M V
Roy Sunilendu B
Binnor Anil K., Mukkanti Khagga, Suryanarayana M V, & Roy Sunilendu B. (2012). A validated stability-indicating HPLC assay method to investigate stability of Pantoprazole injection with injectable solutions (5 % Dextrose injection and 0.9% Sodium Chloride injection). International Journal of Research in Pharmaceutical Sciences, 3(2), 334–339. Retrieved from https://ijrps.com/home/article/view/3676

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