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A Study of Method Development and Validation for Quantification of Iguratimod in Pharmaceutical Dosage Form by RP-HPLC Method

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A rapid and stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for quantification of Iguratimod in the dosage form to get some more advantages over other methods already developed. The method was validated according to United States Pharmacopeia (USP) guideline with respect to accuracy, precision, specificity, linearity, solution stability, robustness and system suitability. For this, an isocratic condition of mobile phase comprising buffer (pH 2.5) and methanol in a ratio of 58:42, v/v at a flow rate of 1.2 mL/minute over Water symmetry C18, 150 × 3.9 mm, 5μm) column at 25°C temperature was maintained. The method showed excellent linear response with correlation coefficient (R2) values of 0.999 for Iguratimod, which was within the limit of correlation coefficient (R2≥0.995). The percent recovery was found within the acceptance limit of (97.0–103.0%). Intra-and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD≤2.0).

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RP-HPLC, Validation

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"A Study of Method Development and Validation for Quantification of Iguratimod in Pharmaceutical Dosage Form by RP-HPLC Method", International Journal of Emerging Technologies and Innovative Research ( | UGC and issn Approved), ISSN:2349-5162, Vol.5, Issue 1, page no. pp141-150, January-2018, Available at : &

Publication Details

Published Paper ID: JETIR1801027
Registration ID: 171235
Published In: Volume 5 | Issue 1 | Year January-2018
DOI (Digital Object Identifier):
Page No: 141-150
ISSN Number: 2349-5162

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(Volume 5 | Issue 1 | January 2018 |Impact factor 5.87)

Call For Paper | Volume 5 | Issue 1 | Impact factor 5.87

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