KESERAGAMAN KANDUNGAN TABLET AMBROXOL HCl GENERIK DAN BERMEREK DAGANG MENGGUNAKAN METODE SPEKTROFOTOMETRI ULTRAVIOLET

Abstract

Ambroxol HCl is a secretolytic agent used in the treatment of respiratory diseases associated with thick or excessive mucus. This drug works by crushing or breaking mucopolysaccharide acid so that thinner and dilute the mucus layer so it is more easily removed through cough. Level requirement is one measure of the quality of a drug. The drug will optimally give its pharmacological effect if it is in accordance with the specified level. Uniformity of content is done to ensure the quality of a drug. This study aims to determine the uniformity of content on tablets trademark and generic HCl ambroxol using ultraviolet spectrophotometry method. This method begins with the determination of the maximum wavelength and operating time. This study also validated the analytical method with parameter analysis that is linearity, accuracy, precision, limits of detection (LOD), and limits of quantification (LOQ) followed by uniformity of content by ultraviolet spectrophotometry. The results obtained maximum wavelength of 245 nm with stable operating time up to the 5th minute. The result of validation of analysis is obtained by precision and accuracy of method that fulfill requirement, that is for Deviation Standard (SD) value equal to 0,145% and accuracy method with% recovery fulfilling requirement 85% -115%. The obtained linearity value of R2 = 0.9954 with detection limit (LOD) 0.112 ppm and quantification limit (LOQ) of 0.409 ppm. Result of uniformity of content which done from 3 brands of ambroxol HCl, obtained grade average 94,79%, 92,33%, 95,11%. So it can be concluded that the HCl ambroxol tablet content meets the general requirements of not less than 85% and not more than 115% of the amount stated on the label.