title: Development, Validation and Application of RP-HPLC Method: Simultaneous Determination of Antihistamine and Preservatives with Paracetamol in Liquid Formulations and Human Serum.
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.
authors.affiliation: Department of Environmental Sciences and Biotechnology, Hallym University, Chuncheon, Gangwon do 200-702, South Korea.
authors.forename: Najmul
authors.initials: N
authors.lastname: Hasan
authors.affiliation: Division of Biotechnology, Faculty of Science, Maejo University, Chiang Mai 50290, Thailand.
authors.forename: Mathurot
authors.initials: M
authors.lastname: Chaiharn
authors.affiliation: Department of Environmental Sciences and Biotechnology, Hallym University, Chuncheon, Gangwon do 200-702, South Korea.
authors.forename: Umair Ali
authors.initials: UA
authors.lastname: Toor
authors.affiliation: Microbiological Analytical Centre, Pakistan Council of Scientific and Industrial Laboratories Complex, Karachi, Pakistan.
authors.forename: Zulfiqar Ali
authors.initials: ZA
authors.lastname: Mirani
authors.affiliation: Quality Assurance, Taj Fisheries (Pvt) Ltd, Fish Harbour, West Wharf, Karachi, Pakistan.
authors.forename: Ghulam
authors.initials: G
authors.lastname: Sajjad
authors.affiliation: Department of Chemistry, Faculty of Science, University of Karachi, Karachi 75270, Pakistan.
authors.forename: Nawab
authors.initials: N
authors.lastname: Sher
authors.affiliation: Department of Pathobiology, Faculty of Veterinary Sciences, Bahauddin Zakariya University, Multan, Pakistan.
authors.forename: Mubashir
authors.initials: M
authors.lastname: Aziz
authors.affiliation: Faculty of Pharmacy, Federal Urdu University of Arts, Science & Technology, Karachi 75300, Pakistan.
authors.forename: Farhan Ahmed
authors.initials: FA
authors.lastname: Siddiqui
keywords: Cetirizine HCl; Oral solution; Paraben; Paracetamol; Preservatives; RP-HPLC