Development, Validation and Application of RP-HPLC Method: Simultaneous Determination of Antihistamine and Preservatives with Paracetamol in Liquid Formulations and Human Serum



Najmul Hasan1, *, Mathurot Chaiharn2, Umair Ali Toor1, Zulfiqar Ali Mirani3, Ghulam Sajjad4, Nawab Sher5, Mubashir Aziz6, Farhan Ahmed Siddiqui7
1 Department of Environmental Sciences and Biotechnology, Hallym University, Chuncheon, Gangwon do 200-702, South Korea
2 Division of Biotechnology, Faculty of Science, Maejo University, Chiang Mai 50290, Thailand
3 Microbiological Analytical Centre, Pakistan Council of Scientific and Industrial Laboratories Complex, Karachi, Pakistan
4 Quality Assurance, Taj Fisheries (Pvt) Ltd, Fish Harbour, West Wharf, Karachi, Pakistan
5 Department of Chemistry, Faculty of Science, University of Karachi, Karachi 75270, Pakistan
6 Department of Pathobiology, Faculty of Veterinary Sciences, Bahauddin Zakariya University, Multan, Pakistan
7 Faculty of Pharmacy, Federal Urdu University of Arts, Science & Technology, Karachi 75300, Pakistan


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© Hasan et al.; Licensee Bentham Open

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0) (https://creativecommons.org/licenses/by-nc/4.0/legalcode), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Department of Environmental Sciences and Biotechnology, Hallym University, Chuncheon, Gangwon do 200-702, South Korea; Tel/Fax: +82-101-2616-7470; E-mail: najam.edu.pak@gmail.com


Abstract

In this article we describe development and validation of stability indicating, accurate, specific, precise and simple Ion-pairing RP-HPLC method for simultaneous determination of paracetamol and cetirizine HCl along with preservatives i.e. propylparaben, and methylparaben in pharmaceutical dosage forms of oral solution and in serum. Acetonitrile: Buffer: Sulfuric Acid (45:55:0.3 v/v/v) was the mobile phase at flow rate 1.0 mL min-1 using a Hibar® Lichrosorb® C18 column and monitored at wavelength of 230nm. The averages of absolute and relative recoveries were found to be 99.3%, 99.5%, 99.8% and 98.7% with correlation coefficient of 0.9977, 0.9998, 0.9984, and 0.9997 for cetirizine HCl, paracetamol, methylparaben and Propylparaben respectively. The limit of quantification and limit of detection were in range of 0.3 to 2.7 ng mL-1 and 0.1 to 0.8 ng mL-1 respectively. Under stress conditions of acidic, basic, oxidative, and thermal degradation, maximum degradation was observed in basic and oxidative stress where a significant impact was observed while all drugs were found almost stable in the other conditions. The developed method was validated in accordance with ICH and AOAC guidelines. The proposed method was successfully applied to quantify amount of paracetamol, cetirizine HCl and two most common microbial preservatives in bulk, dosage form and physiological fluid.

Keywords: Cetirizine HCl, Oral solution, Paraben, Paracetamol, Preservatives, RP-HPLC.