An Integrated HPLC Assay Technique for the Detection of Omeprazole in Mixed Dose Forms with Aspirin, Diclofenac or Domperidone

Abstract

Omeprazole (OMP), which is given for treatment in conjunction with a number of medications, is drawing increased attention for its capacity to reduce gastric acid formation. Commonly administered OMP-loaded dose forms include aspirin (ASN), diclofenac (DCF) and domperidone (DMP). As a result, a single liquid chromatographic approach, which can simultaneously determine OMP-ASN, OMP-DCF or OMP-DMP in commercial formulations was developed. On a reverse-phase Agilent Eclipse XBD C18 analytical column (4.6 × 150 mm; 3.5 (m), the requisite separation was accomplished utilizing a gradient flow of the mobile phase made up of a mixture of solvents A and B (50:50 v/v) and diode array detection at 272 nm. Where solvent A is acetonitrile:buffer-A:buffer-B (10:90:50 v/v/v) and solvent B is acetonitrile:buffer-A:buffer-B (90:10:50 v/v/v). The buffer-B is made up of an equal mixture of 100 mM acetic acid and 100 mM triethyl-amine with a final attained pH of 5.2, whereas the buffer-A is made up of 10 mM trifluoroacetic acid (pH adjusted to 2.2). According to ICH Q2(R1) criteria, the method had been validated and verified the senstivity of the proposed method with a linearity range of 0.5-20 mcg/mL for all the analytes. The established technique for concurrently quantifying OMP with DCF, ASN or DMP in commercial formulations can be regularly employed in the quality control laboratory in accordance with the validation conditions.