A NOVEL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF NEFOPAM HYDROCHLORIDE IN PARENTERAL DOSAGE FORM BY RP-HPLC METHOD
Keywords:Nefopam hydrochloride, RP-HPLC, Method development, Forced degradation studies
Objective: Using RP-HPLC, a simple, accurate, and exact method for estimating the Nefopam Hydrochloride parenteral dose form was devised.
Methods: The isocratic mode of the RP-HPLC method used an Inertsil C8 column as the stationary phase and a mobile phase of potassium dihydrogen phosphate with pH 3.0: Acetonitrile (70:30) at a flow rate of 1 ml/min. With UV detection at 220 nm, a flow rate of 1 ml/min was established.
Results: The developed RP-HPLC technique revealed acceptable linearity (R2 = 0.9998) and good assay results in the concentration range of 0.004–0.08 mg/ml (103.3 percent). Further forced degradation investigations using 0.1N Hydrochloric acid (acid degradation), 0.1NNaOH (base degradation), and 3 percent H2O2 (Hydrogen peroxide) were carried out using RP-HPLC, and percent degradation values were determined. In peroxide degradation conditions, the medication was shown to be unstable.
Conclusion: In compliance with ICH requirements, the developed procedures were validated.
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