Validation of analytical method for determination of furosemide in extemporaneous syrup
Keywords:furosemide, extemporaneous preparation, UV spectrophotometry, validation of analytical method.
Introduction. Extreme syrups can be manufactured using substances or ready medicinal drugs as the active pharmaceutical ingredient. There is a necessity in the development and validation of analytical methods that can be used for quality control of pharmaceutical manufacturing of syrups containing furosemide.
The aim of the study – to develop and validate assay method for furosemide in extemporaneous syrups prepared from both pure substance and finished products. Methods of the research. For proposed UV spectrophotometric assay method the conditions of analysis, sample preparation and validation characteristics were defined. Suspensions of substance and crushed commercial tablets were dissolved in 0.1 M sodium hydroxide solution and evaluated spectrophotometrically in ultraviolet region of light at a wavelength 271 nm using method of specific absorbance.
Results and Discussion. Samples comply with the Beer-Lambert Bouguer law within the concentration range of 8×10-3 – 1.2×10-2 mg/ml with correlation coefficients ≥ 0.9981. The uncertainty of the methods was well within the critical value of the error (0.72 %≤ maxΔAs) for both samples of syrup containing pure substance and commercial tablets. Recovery studies for furosemide in syrup samples of substance and crushed commercial tablets yielded 99.92 ±0.54 % and 99.14±0.16 % respectively. Assay limit of ±10 % by the validation parameters: specificity, linearity, precision, accuracy within the range of 80–120 % of the nominal contents was met by all compounded preparations.
Conclusions. The results of validation proved that this method can be reproduced correctly and is suitable for use in pharmaceutical analysis. Adoption of this method is planned in evaluating uniformity of content and, in combination of other methods, ascertain chemical stability study of compounded furosemide syrups.
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