Journal :   Asian Journal of Research in Chemistry

Volume No. :   5

Issue No. :  7

Year :  2012

Pages :   859-865

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Method Development and Validation for Estimation of Related Compounds Present in Lansoprazole Bulk Drug by Ultra High Pressure Liquid Chromatography

Address:   T. Krishnamohan1*, G. lalitha1, Ramakant V. Sharma1, L. Sambasivarao1, J. Moses babu1, Mohammad Younus2, Aluri Solomon Raju3, Y.L.N.Murthy3
1Dr. Reddy’s Laboratories Ltd, Hyderabad, Andhra Pradesh, India
2Chandra Labs, Hyderabad, Andhra Pradesh, India
3Andhra University, Vishakhapatnam, Andhra Pradesh, India
*Corresponding Author

Objective: Lansoprazole is a proton pump inhibitor which prevents the stomach from producing acid. Lansoprazole contains not more than 0.7% of total impurities of which Sulphone (related compound A) is 0.3%, N-Oxide (related compound B) is 0.1%, Sulphide (related compound C) is 0.1% and any other unknown impurities 0.1%. The aim of the present investigation is to develop a precise and accurate method for the separation and quantification of related substances present with Lansoprazole using Ultra high pressure Liquid Chromatography (UHPLC). Materials and Methods: The separation was achieved on Hypersil Gold C18, (2.1 x 100 mm, 1.8 µ) column. Solvent A water and solvent B acetonitrile: water: tryethylamine (80: 20: 0.005), the pH of the solvent B adjusted to 7 with ortho phosphoric acid were used as gradient elution mobile phase components. The flow rate was set at 0.3 mL/min and eluent was monitored at 285 nm. The method was validated as per ICH guidelines. Results: All related substances were well separated from Lansoprazole in optimized chromatographic conditions. Linearity of the method was studied between 25%-150% targeted concentration regression coefficients found to be as 0.9996, 9991, 09998 and 09995 for N-Oxide, Sulphone, Sulphide and Lansoprazole respectively. % Relative Standard Deviation (%RSD) for Precision, Recovery studies, Accuracy studies at quantification level was less than 2. Conclusions: The developed method is linear, accurate, precise, robust and specific, being able to separate the related substances from Lansoprazole. It may find application for the routine analysis of the related substances of Lansoprazole.
Ultra High Pressure Liquid Chromatography, Lansoprazole, Related compounds, ICH guidelines, Proton pump inhibitor.
T. Krishnamohan, G. lalitha, Ramakant V. Sharma, L. Sambasivarao, J. Moses babu, Mohammad Younus, Aluri Solomon Raju, Y.L.N.Murthy. Method Development and Validation for Estimation of Related Compounds Present in Lansoprazole Bulk Drug by Ultra High Pressure Liquid Chromatography. Asian J. Research Chem. 5(7): July, 2012; Page 859-865.
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