CFIA-ISNAG fluorimeter for the Determination of Bromhexine-HCl in Drugs via the Measurement Scattered Light at ± 90˚

Abstract

A precise, simple, and accurate continuous flow injection technique was used for the instantaneous estimation of bromhexine hydrochloride (BH-HCl) in tablet dosage form. The chemical and physical parameters of the reaction of BH-HCl with tetraphenylborate to produce a yellowish-white precipitate were determined using an ISNAG fluorimeter analyzer and diverging light at 90°. The calibration curve for BH-HCl was linear with correlation coefficients of 0.9994 and linearity percentage r2% = 99.87 over a concentration range of 0.01-20 mmol/L, L.O.D = 0.3610 µg/125µL (0.007 mmol/L), and RSD% less than 0.3% for 3 and 13 mmol/L (five replicates). This approach was efficiently used to estimate the levels of BH-HCl in two distinct pharmaceutical companies. When the newly developed method was compared with the turbidimetric method using a t-test and standard addition, it was discovered that there had not been any significant difference between the two approaches at the 95% level of confidence.