UV-AUC method development and validation for estimation of Dextromethorphan hydrobromide

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DOI: 10.4103/2231-4040.197331

A simple, rapid, accurate and economical UV-spectrophotometric method has been developed for estimation of Dextromethorphan hydrobromide from bulk and pharmaceutical formulation. Method applied was area under curve (AUC) in which area under curve was integrated in the wavelength range of 258.4 – 290.8 nm. The ?max of Dextromethorphan hydrobromide in 0.1N HCL was found to be 281 nm. The drug follows linearity in the concentration range 30 - 80µg/ml with correlation coefficient value 0.999. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 101.42 % was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120 %. The % recovery was found to be in the range 99.2%– 101.76%. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. The above method was a rapid and cost-effective quality-control tool for routine analysis of Dextromethorphan hydrobromide in bulk and in pharmaceutical dosage form

Keywords: Dextromethorphan hydrobromide, UV, validation, quantitative determination