Research Journal of Pharmacy and Technology

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Development and Validation of Stability Indicating Rp-hplc Method for Quantitative Estimation of Ornidazole and Its Impurities in Ornidazole Injection


Affiliations
1 Department of Chemistry, V.S.R Government Degree and P.G. College, Movva, Andhra Pradesh, India
2 Department of chemistry, Acharya Nagarjuna university, Nagarjuna Nagar, Guntur, Andra pradesh, India
     

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The analysis of improved RP-HPLC method for the separation and quantification of Ornidazole and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Symmetry shield RP18, 250 x 4.6 mm, 5μm, and the mobile phase consists of phosphate buffer: methanol in the ratio of 70:30 %v/v. The flow rate is 1.0 ml/min. The column temperature was maintained at 25°C and sample temperature was maintained at ambient (25°C) and wavelength fixed at 318nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Ornidazole impurities are straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, accuracy, solution stability and robustness. Validation study compared as per ICH guideline.

Keywords

Ornidazole injection, Estimation of related substances, Liquid chromatography, Validation.
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  • Development and Validation of Stability Indicating Rp-hplc Method for Quantitative Estimation of Ornidazole and Its Impurities in Ornidazole Injection

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Authors

N. Prasad Babu
Department of Chemistry, V.S.R Government Degree and P.G. College, Movva, Andhra Pradesh, India
D. Ramachandran
Department of chemistry, Acharya Nagarjuna university, Nagarjuna Nagar, Guntur, Andra pradesh, India

Abstract


The analysis of improved RP-HPLC method for the separation and quantification of Ornidazole and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Symmetry shield RP18, 250 x 4.6 mm, 5μm, and the mobile phase consists of phosphate buffer: methanol in the ratio of 70:30 %v/v. The flow rate is 1.0 ml/min. The column temperature was maintained at 25°C and sample temperature was maintained at ambient (25°C) and wavelength fixed at 318nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Ornidazole impurities are straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, accuracy, solution stability and robustness. Validation study compared as per ICH guideline.

Keywords


Ornidazole injection, Estimation of related substances, Liquid chromatography, Validation.

References