DETERMINATION OF R-ISOMER IMPURITY OF PANTOPRAZOLE SODIUM IN A BULK DRUG SUBSTANCE BY NORMAL PHASE CHIRAL LIQUID CHROMATOGRAPHY METHOD
Keywords:Pantaprazole, Chiralpak AD-H, Chiral HPLC, Validation, Solution and mobile phase stability
Objective: To develop novel, simple and rapid R-isomer impurity determination of Pantoprazole sodium by normal-phase high-performance liquid chromatographic method as per ICH guidelines.
Methods: The R-isomer and S-isomer were baseline resolved on a Chiralpak AD-H, (250 x 4.0 mm i.d, 5 mm) column using a mobile phase system containing n-Hexane: Ethanol: Trifluoroacetic acid (80:20:0.1 v/v/v.) at detector wavelength 290 nm and column temperature 20 Â°C. The chromatographic resolutions between R-isomer and S-isomer were found three. The developed method was extensively validated according to ICH guidelines.
Results: Good linearity was observed for R-isomer impurity over the concentration range of 200â€“2000 ng/ml, with the linear regression (Correlation coefficient R = 0.999) and proved to be robust. The limit of detection and limit of quantification of R-isomer was found to be 200 and 600 ng/ml, respectively for 20 ml injection volume. The percentage recovery of R-isomer was ranged from 97.0 to 102.0 in bulk drug samples of Pantoprazole sodium. Pantoprazole sodium sample solution and mobile phase were found to be stable for at least 48 hours. The proposed method was found to be suitable and accurate for the quantitative determination of R-isomer impurity in bulk drugs.
Conclusion: A novel, simple and rapid R-isomer impurity determination of Pantoprazole sodium by normal-phase high-performance liquid chromatographic method was developed and validated as per ICH guidelines.
The developed method can be used for the quantitative determination R-isomer impurity in bulk drug materials in pharmaceutical industry.
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