Method Development and Validation of Assay of Chlorpromazine Hydrochloride Tablet Formulation Using Ultra Violet Visible Spectrophotometry

Abstract

The International Conference on Harmonisation [Q2 (R1)] guidelines was applied for this one-step spectrophotometric estimation of chlorpromazine hydrochloride in neurazine tablet formulation. The method was found to be simple, safe, sensitive, and validated for the assay of chlorpromazine hydrochloride using bromophenol blue, citrate buffer pH 3, and water as diluents. It was also found to be an accurate, reproducible, and cost-effective quality-control tool for the routine analysis of chlorpromazine hydrochloride in standard and pharmaceutical forms. Method Development and Validation of Assay of Chlorpromazine Hydrochloride Tablet Formulation Using Ultra Violet Visible SpectrophotometryLaila A Al Shatti* Diluent preparationDistilled water was used as a diluent. Standard preparationA bromophenol blue (1×10 -3 M) and Cpn-HCl (1×10 -3 M) stock solution was prepared to be used for the preparation of standard solutions. In 100 mL volumetric flasks, 15 mL BrPB, 3 mL citrate buffer (pH 3), and different aliquots of Cpn-HCl (1×10 -3 M) were added to prepare five standard solutions of Cpn-HCl ranging in concentration from 2.553-16 ppm. The five standard solutions were scanned for the maximum wavelength (nm) previously assigned, and a calibration curve was set to perform the linearity test. Pharmaceutical test preparationTen tablets of neurazine formulation were ground and weighed (4.4870 g). Each tablet contained 100 mg active ingredient of Cpn-HCl. To prepare the stock solution (1×10 -3 ) of the formulation, 0.1594 g of the ground tablets were weighed and dissolved with distilled water in a 100 mL volumetric flask. The stock solution was diluted to prepare (1×10 -4 M). A test solution was made by adding 15 mL bromophenol blue, 3 mL citrate buffer (pH 3), and 10 mL neurazine (1×10 -4 M) (ppm). The solution was tested by the extrapolation method to determine the concentration of the neurazine test sample. InstrumentationA UV-visible double beam spectrophotometer with matched quartz cell (1 cm) (model no. Evolution 201) by Thermo Scientific, 81 Wyman Street Waltham, Massachusetts, US was used. Results and Discussion Development and optimization of the spectrophotometric methodThe selection of the proper wavelength in this method depends on the sample, diluent, and test solution. Spectrophotometric quantitative determination of chlorpromazine needs the development of rugged and suitable conditions after testing different parameters, such as diluents, buffer, buffer concentration, and other chromatographic conditions. Different trials with varied compositions of diluents and buffer should be conducted to choose the optimum conditions. Selection of wavelengthThe standard solution and the pharmaceutical test forms were scanned by UV-visible spectrophotometer between 200 and 700 nm on spectrum mode before and after using BrPB (Figures 1 and 2). Both spectra showed that Cpn-HCl has a maximum wavelength λ max at 314. Bromophenol blue was scanned to avoid the interferences of wavelengths (Figure 3). The spectrum pf BrPB ...

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