Development and Validation of some Analytical Methods for Quantitative Determination of hyoscine butyl bromide

Abstract

Method validation is the process used to confirm that the analytical procedure employed for specific test is suitable for its intended use. Result from method validation can be used to judge the quality, reliability and consistency of analytical results; it is integral part of any good analytical practice. When extended to analytical procedure depending upon the application, it means that a method work reproducibly, when carried out by same or different persons, in same or different laboratories , using different chemicals or reagents and using different equipments at different condition or environment. The aim of the this study was to develop and validate HPLC method and UV Spectrophotometeric method for the determination of hyoscine butyl bromide. In RP- HPLC a mixture 1.0 g of sodium dodecyl sulfate in a mixture of 370 mL of 0.001M hydrochloric acid and 750 mL of methanol (in 1000 ml) (v/v) was used as a modified mobile phase mixture. the column was C8 (25×4.6mm). The flow rate was set to 2ml/mint. The method was validated regarding linearity, range, limit of detection, limit of quantitation, precision, and accuracy. The obtained results showed that the validated method have good linearity, accuracy, precision and selectivity and reducing the retention time of hyoscine butyl bromide from (14.26) minutes to (9.0) minutes. Analytical method development results indicated thatthe limit of detection was (0.0054µg/ml), limit of quantitation was (0.0165µg/ml) and assay exhibited a linear over the range of (10-50µg/ml). The modified method of chromatography gave a linear relationship at a wavelength of 210 nm, linear correlation coefficient (0.998).

In the UV, The method validated according to international conference on harmonization guideline, linearity range, and limit of detection, limit of quantitation, precision, and accuracy. The modified method of UV gave a linear relationship at a wavelength of 257 nm, linear correlation coefficient (0.9999).The validated method showed results the indicated limit of detection was (0.0139µg/ml), limit of quantitation was (0.0423µg/ml).

Respectively results Were compared with the official method were conducted analyzes in two different days to determine relative standard deviation which did not exceed 2%, the developed methods in present research successfully in the quantitation analysis of commercial preparation tablets of different sources. The study summarized the results of the analysis are not different from those obtained by official method approved therefore developed method considered to be fit, the best because fast, inexpensive and more safe, which can be of use for routine analysis drug lab.