STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF OCTOPAMINE IN PHARMACEUTICAL DOSAGE FORM
Keywords:OctopamineHCl, RP-HPLC, Validation, ICH guidelines
Objective: Â To develop simple and cost effective Reverse Phase High Performance Liquid Â Â Chromatographic (RP-HPLC) method for the estimation of Octopamine.HCl in pharmaceutical dosage form. Methods: Â The estimation was carried out on SUNFIRE C18 (150*4.6mm, 5m ) using mobile phase consisting of phosphate buffer of pH (2.54) and Acetonitrile (90:10). The flow rate was 1.0 ml/min column effluents were monitored at 273 nm. The proposed method has been validated as per ICH Guidelines. Results: The retention time was 2.9 minute and the proposed method was linear in the concentration range of 5 to30 Î¼g/ml with coefficient of correlation 0.9998. The percent recoveries at 99percent-101percent were found to be 99.1percent, 98.57percentand 98.23percent respectively.Â Conclusion: All the validation parameters were within the acceptance range. The developed Â Â method can successfully be applied for the routine estimation of the amount of octopamine in bulk and pharmaceutical dosage form. The proposed method can be used to determine the drug content in various pharmaceutical dosage forms.
Â Key words: Octopamine.HCl, RP-HPLC, Validation, ICH guidelines
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