HPLC METHOD FOR DETERMINATION OF PARACETAMOL, PSEDOEPHEDRINE, TRIPROLIDINE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, AND THEIR RELATED SUBSTANCES IN PHARMACEUTICAL SYRUP

Abstract

A validated HPLC method was developed for the analysis of paracetamol, psedoephedrine, triprolidine, methylparaben, propylparaben, sodium benzoate, and their related substances including p-aminophenol, triprolidine Z-isomer, 4-hydroxy benzoic acid, and 4-chloracetailide in syrup using symmetry C18 column at 25°C with UV detection at 214 nm. A linear gradient elution was employed starting with 100% mobile phase A and 0% mobile phase B for 5 min to reach 40% mobile phase A and 60% mobile phase B at 16 min then 0% mobile phase A and 100% mobile phase B at 28 min. Total run time is 30 min using solution of 28 mM sodium dihydrogen phosphate containing 2.6 mM hexanesulphonic acid sodium salt and adjusted to apparent pH 3.0 with phosphoric acid–acetonitrile in ratios of (90:10 v/v) and (60:40 v/v) as mobile phase A and mobile phase B, respectively. 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 completely validated.

Keywords:

• HPLC
• paracetamol
• preservatives
• psedoephedrine
• related substances
• triprolidine

ACKNOWLEDGMENT

We would like to thank Gulf Pharmaceutical Industries (Julphar), RAK, UAE for its support to perform this study.

Notes

(*) Y = a + bC, where C is the concentration in µg/mL and Y is the peak area.

(**) C.V. for the values of peaks area/concentration (µg/mL) for 21 replicates.

^a Mean ± SD for five determinations.

*Each 5 mL of rinofed plus syrup was labeled to contain 1.25 mg TR, 25 mg PS, 125 mg PA, and 20 mg SB.

^a Mean ± SD for five determinations.

*Each 5 mL of sedofan syrup was labeled to contain 1.25 mg TR, 25 mg PS, 5 mg MP, and 1.5 mg PP.

^a Mean ± SD, percentage recovery from the label claim amount.

^b Theoretical values for t and F at P = 0.05.