Validation of analytical procedures: Text and methodology Q2 (R1). USA: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Validation of Analytical Procedures Q2 (R2). Petunjuk pelaksanaan validasi metode dan cara perhitungannya.
Salts of therapeutic agents: Chemical, physicochemical, and biological considerations.
Gupta, D., Bhatia, D., Dave, V., Sutariya, V., & Gupta, S. Research Journal of Pharmacy and Technology, 6(2), 200–203. Development and validation of High Performance Liquid Chromatography method for simultaneous estimation of ambroxol and doxofylline in their combined tablet dosage form. Indonesian Journal of Clinical Pharmacy, 10(3), 172–179.
The beyond-use dates perception of drugs in North Jakarta, Indonesia. Austin Chromatography, 1(2), 1–4.Ĭokro, F., Arrang, S. HPLC calibration process parameters in terms of system suitability test. A Rapid, Developed and Validated RP-HPLC Method for Determination of Azithromycin. In conclusion, the extrapolation result showed that the BUD ambroxol HCl syrup was 83 days for sample A and B, and 49 days for sample C, D, and E.Īl-Hakkani, M. Normality test data result indicated that data must be divided into two groups that are sample A and B, and sample C, D, and E. The ambroxol HCl level on all samples was still higher than 90% (until the 36th day). This method meets the requirements according to the ICH Q2(R1) guidelines and can be used for the assay of ambroxol HCl syrup. It is also fulfilled the accuracy and precision parameters with a % recovery from 99.04% to 100.94% and CV<2%. LOD and LOQ for ambroxol HCl were 0.74 µg/ml and 2.25 µg/ml, respectively. In the validation, ambroxol HCl showed good linearity with r = 0.99985 in the 6 to 36 µg/ml. The retention time for ambroxol HCl was 4.62 minutes. To determine BUD, five syrup preparations (brands) obtained from the Jakarta area were analyzed in triplicate. The HPLC conditions were reversed-phase with a C18 column, mobile phase containing acetonitrile - phosphate buffer 0.05 M pH 4.5 (60:40) at a flow rate of 1.0 ml/min using UV detection at 248 nm. This study aims to determine the beyond-use date (BUD) of ambroxol HCl syrup on the market based on analysis of the decrease in drug content using High-Performance Liquid Chromatography (HPLC) – UV/Vis detector. Ambroxol HCl is a mucolytic agent often used to treat respiratory disorders associated with excess mucus secretion.
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