DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMOXYCILLIN AND SULBACTAM IN BINARY MIXTURE
Journal Title: Int J of Pharm Rev& Res - Year 2015, Vol 5, Issue 1
Abstract
A simple, precise, rapid and accurate RP- HPLC method was developed for simultaneous estimation of Amoxycillin (AMX) and Sulbactam (SUL) in Pharmaceutical dosage forms using Inertsil ODS 4.6x250mm, with 5 μm particle size. The mobile phase composed of acetonitrile: phosphate buffer (50mM KH2PO4) in the ratio of 10:90v/v (pH adjusted to 4.6 with orthophosphoric acid) was used for separation. The flow rate was maintained at 1.2 ml/min and the effluents were monitored at 238 nm. The retention times observed for Amoxycillin and Sulbactam were 3.297min and 5.157 respectively. The detector response was linear in the concentration of 336 - 784 μg/ml for AMX and 144-336 μg/ml for SUL. The Limit of Detection (LOD) is 399.45μg for AMX and 1481.967μg for SUL. The Limit of Quantification (LOQ) is 1210.441μg for AMX and 4490.81μg for SUL. The percentage assay of AMX and SUL were found to be 99.16%, 98.19% respectively. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of AMX and SUL in bulk drug and in its pharmaceutical dosage forms.
Authors and Affiliations
P. Chandana⃰⃰ , N. Srinivas , G. Tuljarani
Keywords
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