Author(s)

Md. Nazmus Sakib Chowdhury^1*, Sreekanta Nath Dalal², Md. Ariful Islam³, Md. Anwar Hossain⁴, Pranab Kumar Das⁵, Shakawat Hossain⁶, Parajit Das⁷

¹Department of Pharmacy, Bangabandhu Sheikh Mujibur Rahman Science and Technology University, Gopalganj, Bangladesh.
²Department of Applied Chemistry and Chemical Engineering, University of Dhaka, Dhaka, Bangladesh.
³Department of Applied Chemistry and Chemical Engineering, University of Chittagong, Chattogram, Bangladesh.
⁴Department of Applied Chemistry and Chemical Engineering, Islamic University, Kushtia, Bangladesh.
⁵Department of Applied Chemistry and Chemical Engineering, University of Rajshahi, Rajshahi, Bangladesh.
⁶Department of Pharmacy, International Islamic University Chittagong, Chittagong, Bangladesh.
⁷Department of Applied Chemistry and Chemical Engineering, Bangabandhu Sheikh Mujibur Rahman Science and Technology University, Gopalganj, Bangladesh.

Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical method variation parameters are based on pH variability of buffer solution of mobile phase, organic ratio composition changes, stationary phase (column) manufacture, brand name and lot number variation; flow rate variation and temperature variation of chromatographic system. The analytical chemical method for assay of Atropine Sulfate conducted for robustness evaluation. The typical variation considered for mobile phase organic ratio change, change of pH, change of temperature, change of flow rate, change of column etc. Purpose: The aim of this study is to develop a cost effective, short run time and robust analytical chemical method for the assay quantification of Atropine in Pharmaceutical Ophthalmic Solution. This will help to make analytical decisions quickly for research and development scientists as well as will help with quality control product release for patient consumption. This analytical method will help to meet the market demand through quick quality control test of Atropine Ophthalmic Solution and it is very easy for maintaining (GDP) good documentation practices within the shortest period of time. Method: HPLC method has been selected for developing superior method to Compendial method. Both the compendial HPLC method and developed HPLC method was run into the same HPLC system to prove the superiority of developed method. Sensitivity, precision, reproducibility, accuracy parameters were considered for superiority of method. Mobile phase ratio change, pH of buffer solution, change of stationary phase temperature, change of flow rate and change of column were taken into consideration for robustness study of the developed method. Results: The limit of quantitation (LOQ) of developed method was much low than the compendial method. The % RSD for the six sample assay of developed method was 0.4% where the % RSD of the compendial method was 1.2%. The reproducibility between two analysts was 100.4% for developed method on the contrary the compendial method was 98.4%.

Robustness, Method Validation, HPLC, Compendial Method, Method Development, GDP, LOQ

Chowdhury, M. , Dalal, S. , Islam, M. , Hossain, M. , Das, P. , Hossain, S. and Das, P. (2024) Robustness Study and Superior Method Development and Validation for Analytical Assay Method of Atropine Sulfate in Pharmaceutical Ophthalmic Solution. American Journal of Analytical Chemistry, 15, 151-164. doi: 10.4236/ajac.2024.155010.