Abstract
Development and Validation of an RP-HPLC Method for Estimation of Secnidazole and Its Degradation Products in Tablets
Highlights
Secnidazole is chemically designated as (RS)-1-(2-methyl-5nitroimidazole-1-yl) propan-2-ol.It is a long-lasting nitroimidazole antimicrobial agent and used in treatment of amoebiasis, giardiasis and trichomonasis
The organic solvent was changed to 15% THF which was estimated by solvent-monograph based on the 30% methanol, the retention times was 9.08 minute for secnidazole but the peak of 1-methyl-5-nitraimidazole was eluted at baseline disturbance
In the chromatogram obtained with test solution (0.5mg/ mL) the area of any secondary peak is not more than the area of peak in the chromatogram obtained with reference solution (0.005mg/mL) (1%) and the sun of areas of all the secondary peak is not more than 2 times (2%) the area of the peak in the chromatogram obtained with reference solution (0.005mg/ mL)(2%) [19]. the results in Table 6 shown that, the individual area did not exceed 1% in both method. there was no significant difference between two method for determination degradants (2-methyl-5- nitroimidazol ) and unknown 1 but there was statistical significant difference between the two method for determination of isosecnidazole but practical no significant difference because the recovery of the proposed method was inside 75-125% limit
Summary
Secnidazole is chemically designated as (RS)-1-(2-methyl-5nitroimidazole-1-yl) propan-2-ol. Determination of linearity for assay of secnidazole Different aliquots of stock standard solution (0.5mg/mL) were transferred into a series of volumetric flask, and diluted to the mark with mobile phase to obtain final concentrations of 50μg/mL , 70 μg/ mL , 100 μg/mL , 120 μg/mL and 150 μg/mL. Different aliquots of standard solution (5μg/mL) were transferred into a series of volumetric flask; placebo (44.8mg) was added to each volumetric flask and diluted with mobile phase to volume to obtain final concentrations of 0.12μg/ mL, 1.24μg/mL, 1.2μg/mL, 2.4μg/mL and 7.2μg/mL. An accurately measured aliquot (1mL) of stock standard solution (0.5mg/mL) was transferred into a 100mL volumetric flask , placebo (44.8mg) was added the volumetric flask and diluted with mobile phase to volume to obtain final concentration of 5μg/mL The final solution was filtered through syringe filter (0.45μm).
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