DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR QUANTITATIVE ESTIMATION OF NIMBOLIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Objective: The present study was aimed to a simple, new, rapid and highly sensitive Reverse Phase - High Performance Liquid Chromatographic (RP-HPLC) method has been developed and an assay was validated for the quantitative estimation of nimbolide in solid dosage form.
Methods: The chromatographic separation was achieved on an Agilent 1200 series HPLC system C18 (250 mm x 4.6 mm x 2.5 Î¼) column packing by using isocratic mobile phase consisting of acetonitrile: water (90:10 v/v), flow rate was adjusted to 1.0 ml/min at a fixed wave length of 207 nm.
Results: The nimbolide was eluted at 2.880 Â± 0.05 min and established a dynamic range of linearity over the concentration range of 3.125-200 ppm/ml (r2Â = 0.9997 Â± 0.005). The lower limit of detection and quantification was 0.007 ppm/ml and 0.021 ppm/ml respectively. The method was validated as per ICH guidelines. The accuracy of the method was determined by the recovery studies and the mean recovery was obtained 98.27%. Moreover the method was shown good reproducibility and recovery with percent relative standard deviation less than 2%.
Conclusion: Rapid, efficient and sensitive RP-HPLC method was developed for the estimation of nimbolide from the perspective of reducing the cost of analysis and time and thus by saving laboratory resources.
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