Abstract
Objective: As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial quality by design approach was established and validated for Ambroxol (AMB) by reversed-phase high-performance liquid chromatography (RP-HPLC). Methods: A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, limit of detection (LOD), limit of quantitation (LOQ), accuracy as per International Conference for Harmonisation guidelines (Q2R1). Statistical data analysis was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Auto injector, ultraviolet (UV) diode-array detection and Gradient Detector. Results: Equipped with Reverse Phase (Agilent) C18 column (4.6 mm × 100 mm; 2.5 μm), a 20 μl injection loop and UV730D Absorbance detector at 244 nm wave length and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% orthophosphoric acid) Water (75:25) of pH 3 as mobile phase setting flow rate 0.7 ml/min at ambient temperature the retention time of AMB were found to be 4.85 min. The industrialized method was found linear over the concentration range of 10–50 μg/ml for AMB while the LOD and LOQ of AMB was found to be 0.5174–0.2739 μg/ml, analytical method that concluded. Conclusion: There are no interfering peaks underperformed degradation conditions. Therefore, a sensitive, robust, accurate, and stability indicating method was developed with high degree of practical utility.
Highlights
The concept of “quality by design” (QbD) was defined as an approach that covers a better scientific understanding of critical process and product qualities, designing controls and tests based on the scientific limits of understanding throughout the development phase and by the knowledge obtained during the life-cycle of the product to work on a continuous improvement environment
The main impartial of our work is to develop an improved reversed-phase high-performance liquid chromatography (RP-HPLC) method suitable for the routine quality control of AMB in a pharmaceutical industry and provide information on the sensitivity of chromatographic factors and their interaction effects on the separation characteristics
It is important to establish the critical quality attributes of a system that may impact the quality of the analytical method
Summary
The concept of “quality by design” (QbD) was defined as an approach that covers a better scientific understanding of critical process and product qualities, designing controls and tests based on the scientific limits of understanding throughout the development phase and by the knowledge obtained during the life-cycle of the product to work on a continuous improvement environment. QbD describes a pharmaceutical development approach referring to formulation design and development and manufacturing processes to maintain the prescribed product quality. AMB is indicated as “secretolytic therapy in bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport. It promotes mucus clearance, facilitates expectoration, and eases productive cough, allowing patients to breathe freely and deeply.”
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