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Scientia Pharmaceutica, Autorenhinweise 2012
 
 
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Sci. Pharm.
Volume 81
Issue 4
10.3797/scipharm.1306-06
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Article

Design of Experiment (DOE) Utilization to Develop a Simple and Robust Reversed-Phase HPLC Technique for Related Substances’ Estimation of Omeprazole Formulations

by
Vayeda Chintan MANRANJAN
,
Devendra Singh YADAV
*,
Hitesh Amrutlal JOGIA
and
Praful Lalitkumar CHAUHAN
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2013, 81(4), 1043-1056; https://doi.org/10.3797/scipharm.1306-06
Submission received: 11 June 2013 / Accepted: 12 August 2013 / Published: 12 August 2013
Versions Notes

Abstract

A simple, fast, and sensitive reversed-phase HPLC method with UV detection was developed for the quantitation of omeprazole and its eleven related compounds (impurities) in pharmaceutical formulation using the Thermo Accucore C–18 (50 mm x 4.6 mm, 2.6 μm) column. The separation among all the compounds was achieved with a flow rate of 0.8 mL min−1 employing a gradient program of mobile phase A [0.08 M glycine buffer pH 9.0: acetonitrile; 95:05 (v/v)] and mobile phase B [acetonitrile: methanol; 65:35 (v/v)]. The chromatographic detection was carried out at a wavelength of 305 nm. The method was validated for specificity, linearity, and recovery. The huskiness of the method was determined prior to validation using the Design of Experiments (DOE). The ANOVA analysis of DOE with a 95% confidence interval (CI) confirmed the buffer pH of mobile phase A (p <0.0001) and column temperature (p<0.0001) as significant Critical Method Parameters (CMPs).
Keywords: DOE; HPLC/UPLC; Compatible; Related Substances; Anova; Method development; Chromatography DOE; HPLC/UPLC; Compatible; Related Substances; Anova; Method development; Chromatography

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MDPI and ACS Style

MANRANJAN, V.C.; YADAV, D.S.; JOGIA, H.A.; CHAUHAN, P.L. Design of Experiment (DOE) Utilization to Develop a Simple and Robust Reversed-Phase HPLC Technique for Related Substances’ Estimation of Omeprazole Formulations. Sci. Pharm. 2013, 81, 1043-1056. https://doi.org/10.3797/scipharm.1306-06

AMA Style

MANRANJAN VC, YADAV DS, JOGIA HA, CHAUHAN PL. Design of Experiment (DOE) Utilization to Develop a Simple and Robust Reversed-Phase HPLC Technique for Related Substances’ Estimation of Omeprazole Formulations. Scientia Pharmaceutica. 2013; 81(4):1043-1056. https://doi.org/10.3797/scipharm.1306-06

Chicago/Turabian Style

MANRANJAN, Vayeda Chintan, Devendra Singh YADAV, Hitesh Amrutlal JOGIA, and Praful Lalitkumar CHAUHAN. 2013. "Design of Experiment (DOE) Utilization to Develop a Simple and Robust Reversed-Phase HPLC Technique for Related Substances’ Estimation of Omeprazole Formulations" Scientia Pharmaceutica 81, no. 4: 1043-1056. https://doi.org/10.3797/scipharm.1306-06

APA Style

MANRANJAN, V. C., YADAV, D. S., JOGIA, H. A., & CHAUHAN, P. L. (2013). Design of Experiment (DOE) Utilization to Develop a Simple and Robust Reversed-Phase HPLC Technique for Related Substances’ Estimation of Omeprazole Formulations. Scientia Pharmaceutica, 81(4), 1043-1056. https://doi.org/10.3797/scipharm.1306-06

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