VALIDATION OF HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF PSEUDOEPHEDRINE HCl, GUAIFENESIN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBr

Abstract

Objectives: Pseudoephedrine HCl, Guaifenesin, Chlorpheniramine Maleate and Dextromethorphan HBr combination is a common combination cough syrup. Many validated methods are available for the determination of each compound alone and in combination with other drugs. The local pharmaceutical industry used to analyze such combination in individual assessment which is efforts and time consuming. The objective of this study is to validate a method for simultaneous determinations of the four compounds in one single injection.

Methods: HPLC method had been develop using detector at 210 nm, column C18 4.6 mm × 250 mm, 3µm and mobile phase of Potassium dihydrogen orthophosphate, acetonitrile, orthophosphoric acid, triethanolamine and water. The column oven temperature is 40⁰C, flow rate 0.8 ml/min and 60 minutes run time. The method had been validated according to the ICH guidelines with respect to method specificity, linearity and range, precision, accuracy and robustness. Limit of detection, quantitation limit and solution stability had been assessed.

Results: The average retention times the 4 compounds are 5.5, 12.63, 15.85, 50.44 minutes. The RSD% is less than 1%, the theoretical plates is more than 2000, the tailing factor is not more than 2 and the resolution between the peaks was found to be above 20. The Method showed an appropriate linearity having correlation coefficient r² 0.9996 – 0.9998. The RSD%   of results for two analysts in two different apparatus in two days was less than 2. The test solution is stable for 48 hours.

Conclusion: The method is simple and fulfilled all acceptable criteria for all validation parameters. The method is qualified enough to be used for routine analysis of products containing the four components.

                                  

Peer Review History:

Received: 3 August 2020; Revised: 12 September; Accepted: 22 October; Available online: 15 November 2020

Academic Editor: Rola Jadallah, Arab American University, Palestine, rola@aauj.edu

Received file:                Reviewer's Comments:

Average Peer review marks at initial stage: 5.0/10

Average Peer review marks at publication stage: 7.0/10

Reviewer(s) detail:

Dr. Vijay Kumar Singh, Institute of Pharmacy, Bundelkhand University, Jhansi, India, vijayquantum@gmail.com

Dr. Showkat Ahmad Bhawani, UNIMAS Sarawak Malaysia, sabhawani@gmail.com