Research Article

An HPLC Method for Determination of 15 Pharmaceutical Compounds in Anti-Cold Products

^*1Yasser El-Shabrawy, ²Alaa El-Gindy, ³Maisra Al-Shabrawi Shoeib and ⁴Yassmin El-Gindy

¹Pharmaceutical analytical Department, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt

²Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Suez Canal University, Ismailia 41522, Egypt

³Quality Control Department, Gulf Pharmaceutical Industry (JULPHAR), RAK, United Arab Emirates

⁴Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ajman University, Ajman, United Arab Emirates

*Corresponding author E-mail: yshabrawy_2000@yahoo.com

Accepted 06 November 2014

Abstract

A validated HPLC method was developed for determination of paracetamol, phenylephrine hydrochloride, pseudoephedrine hydrochloride, salicylamide, guaifenesin hydrochloride, sodium benzoate, methylparaben , chlorpheniramine maleate, triprolidine hydrochloride, dextromethorphan hydrobromide, diphenhydramine hydrochloride , promethazine hydrochloride , propylparaben and both of para aminophenol and 4-chloroacetanilide as related compounds for paracetamol in different pharmaceutical dosage forms of anti-cold products such as tablet, syrup, suspension and sachet using symmetry C18 column at 25°C with UV detection at 215 nm. A linear gradient elution was employed starting with 92% mobile phase A and 8% mobile phase B for 6 min to reach 73% mobile phase A and 27% mobile phase B at 20 min then 60% mobile phase A and 40% mobile phase B at 35 min. The total run time is 40 min using solution of 30 mM sodium dihydrogen phosphate containing 3 mM hexanesulphonic acid sodium salt and adjusted to apparent pH 3.0 with phosphoric acid as mobile phase A and acetonitrile as mobile phase B. All mentioned compounds have been successfully separated and quantified using the developed method. The developed method was linear with (r =0.9999) for all compounds. The proposed method was applied successfully for determination of the constituent of 22 anti-cold pharmaceutical products.

Keywords: HPLC, anti-cold products, related substances, preservatives