QUALITY BY DESIGN APPROACH TO DEVELOP STABILITY INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT FOR AMBROXOL
نویسندگان
چکیده
Objective: As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial quality design approach was established validated for Ambroxol (AMB) reversed-phase high-performance liquid chromatography (RP-HPLC). Methods: A simple RP-HPLC has been developed with different parameters such as linearity, precision, repeatability, limit detection (LOD), quantitation (LOQ), accuracy International Conference Harmonisation guidelines (Q2R1). Statistical data analysis done obtained from aliquots Runs on Agilent Tech. Gradient System Auto injector, ultraviolet (UV) diode-array Detector. Results: Equipped Reverse Phase (Agilent) C18 column (4.6 mm × 100 mm; 2.5 ?m), a 20 ?l injection loop UV730D Absorbance detector at 244 nm wave length running chemstation 10.1 software drugs along degradants were separated via Methanol: (0.1% orthophosphoric acid) Water (75:25) pH 3 mobile phase setting flow rate 0.7 ml/min ambient temperature the retention time AMB found to be 4.85 min. The industrialized linear over concentration range 10–50 ?g/ml while LOD LOQ 0.5174–0.2739 ?g/ml, analytical that concluded. Conclusion: There are no interfering peaks underperformed degradation conditions. Therefore, sensitive, robust, accurate, stability indicating high degree practical utility.
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ژورنال
عنوان ژورنال: Asian Journal of Pharmaceutical and Clinical Research
سال: 2021
ISSN: ['0974-2441', '2455-3891']
DOI: https://doi.org/10.22159/ajpcr.2021.v14i12.42939