STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF NALOXONE IN BULK AND PHARMACEUTICAL FORM BY USING RP-HPLC

In the current work, an endeavour be situated made to give a fresher, delicate, basic, precise and minimal effort RP-HPLC technique. It is effectively applied for the assurance of Naloxone in drug arrangements without the obstructions of other component in the details. In HPLC strategy, HPLC conditions were upgraded to get, a sufficient detachment of eluted mixes. At first, different portable stage pieces were attempted, to come to be great ideal outcomes. Portable stage and stream rate choice be subject to on top boundaries (tallness, resulting, imaginary plates, limit factor), run time and so on the milieu with Buffer: acetonitrile (43:57) with 1 ml/min river rate is very strong.The ideal frequency for identification was 254 nm at which better indicator reaction for drug was gotten. The normal conservation time for Naloxone were discovered to be 2.2. Framework appositeness tests are an essential piece of chromatographic strategy. They are applied to check the duplicability of the chromatographic framework. To discover its adequacy, framework reasonableness tests were done on newly arranged stock activities. The alignment was direct in focus scope of 60 – 100 mg/ml. The low estimations of % R.S.D. show the strategy is exact and precise. The mean recuperations be situated found in the scope of 99.8%– 101.4%. Sample worth and quality of the sample were assessed using three illustrations of five and three different concentrations, respectively, prepared and analysed on the same day. Variability on a day-to-day basis was measured using three concentrations analysed over three separate days over a three-day period. The precision also reproducibility of the assay are seen in these data.                        

Keywords: Naloxone, RP‐HPLC, Method development, Validation