Saturday , 24 August 2019

Analytical Method Development and Validation of Naloxone and Oxycodone in Bulk and in its Pharmaceutical Dosage Forms Using RP-HPLC as Per ICH guide lines

Dr. G. Uma soundarya1, Bheemanabhoeina Bhargavi2
1Asst. Professor, Nova College of Pharmaceutical  Education & Research, Jupudi Village, Ibrahimpatnam, Krishna, Vijayawada, Andhra Pradesh, India.

2Nova College of Pharmaceutical Education & Research, Jupudi Village, Ibrahimpatnam, Krishna, Vijayawada, Andhra Pradesh, India.

A B S T R A C T
The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of Naloxone and Oxycodone in tablet dosage form. The developed method was validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. From literature review and solubility analysis initial chromatographic conditions Mobile phase ortho phosphoric acid buffer: Methanol 65:35 were set (Buffer PH 2.45 adjusted with Triethylamine), Kromosil C 18  (250×4.6mm, 5µ) Column, Flow rate 1.0 ml/min and temperature was ambient, eluent was scanned with PDA detector in system and it showed maximum absorbance at 254 nm. As the methanol content was increased Naloxone and Oxycodone got eluted with good peak symmetric properties. The retention times for Naloxone and Oxycodone was found to be 2.589 min and 3.711 min respectively. System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between 50% to150 % levels, R2 value was found to be as 0.999.By using above method assay of marketed formulation was carried out, 100.7% was present. Full length method was not performed; if it is done this method can be used for routine analysis of Naloxone and Oxycodone.
Keywords: Kromosil C18, Naloxone and Oxycodone

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