Analytical Method Development and Validation for Quantitative Estimation of Nonoxynol-9 In Dosage Form by RP-HPLC

Author(s): Hemanth Mandava*, Naga Malleswari. G, Rama Rao. N.

Abstract: The aim of the present work was to develop and validate a simple, efficient, economical method for the estimation of Nonoxynol-9.by reverse phase high pressure liquid chromatography. For Nonoxynol-9 Chromatography was performed on Waters Nova-Pak, C18,3.9mm with mobile phase containing Methanol: water (80:20) at a flow rate of 1 mL/min and eluents were monitored at 280 nm The retention times of Nonoxynol-9 7.307 min and showed a good linearity in the concentration range of 0.50 to 1.50 mg/mL for Nonoxynol-9, with a correlation coefficient of 0.999. The validation characteristics included Specificity, Linearity, Accuracy, Precision, Robustness and Stability. Validation acceptance criteria were met in all cases. The percent recoveries ranged between 97 – 103 %, RSD < 2%. The method could be successfully used for the analysis of Nonoxynol-9 in Drug product.

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