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Abstract

UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF NALTREXONE IN API AND PHARMACEUTICAL DOSAGE FORM

Sagar Sunil Sontakke*, Prof. Afaque Raza Mehboob Ansari, Prashama P. Gawali, Rekha G. Zanwar, Rekha P. Mudke and Sonali N. Koli

ABSTRACT

A simple, precise, accurate, economical and reliable UV spectrophotometric method has been developed for the estimation of Naltrexone in bulk and its tablet dosage form. The drug shows maximum absorption (λmax) at 232 nm in methanol and acetonitrile and obeys Beer‟s law in the concentration range of 10-50 μg/ml with correlation coefficient (R2=0.999). The accuracy was found to be 99.37-100.05 %. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 1.163μg/ml and 3.526μg/ml respectively. The relative standard deviation was found to be <2.0% in all cases. The proposed spectrophotometric method was validated as per ICH Q2 (R1) guidelines. Statistical analysis proved that the method is repeatable and specific for the determination of the said drug. The proposed method can be used for the reliable quantification of Naltrexone in bulk form and routine analysis of pharmaceutical formulations.

Keywords: Naltrexone, UV Spectrophotometer, Method Validation.


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