METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF AMBROXOL HCl IN PHARMACEUTICAL DOSAGE FORMAbstract
Rapid, sensitive, specific and validated colorimetric methods have been developed for the quantitative estimation of ambroxol HCl in bulk and dosage form. The current method was developed based on oxidation of ambroxol with Gibb’s reagent (method I) and p-diethyl amino benzaldehyde in toluene (method II). The formed intense colour complex was measured at 537.2 nm and 438.4 nm respectively. Under optimized experimental conditions, Beer’s law is obeyed in concentration range 5 – 30 µg/ml for both the methods with regression co-efficient 0.9994 and 0.9992. Recovery studies were conducted by standard addition method to confirm the accuracy of the method. The LOD and LOQ for the estimation of ambroxol were found as 0.0773, 0.2343 for method I and 0.0667, 0.2021 for method II respectively. The proposed method was validated as per ICH guidelines.
P. P. Prabhu *, P. Das and N. S. Khushboo
Department of Pharmaceutical Chemistry, Srinivas College of Pharmacy, Valachil, Mangalore, Karnataka, India.
06 September, 2017
17 February, 2018
04 March, 2018
01 June, 2018