A Single HPLC-Dad Method for Simultaneous Analysis of Paracetamol, Phenylephrine, Caffeine and Levocetirizine in Bulk Powder and Tablet Formulation: Application to in-Vitro Dissolution Studies

Abstract

Present work describes development and validation of HPLC-DAD method for the analysis of a complex mixture consisting phenylephrine hydrochloride (PHE), paracetamol (PAR), caffeine (CAF) and levocetirizine (LEV). Chromatographic separation was achieved using a Kinetex-C18 column involving gradient elution, the mobile phase composed of 10mM phosphate buffer (pH 3.3) and methanol. The three step gradient program started with step-1 initially with 2% (by volume) methanol and 98 % phosphate buffer (pH 3.3) for first 5 minutes. In step-2 methanol concentration changed linearly to 80% in next 12 minutes the analysis was concluded by step-3 changing methanol to 2% in next 8 minutes. The method was linear in concentration ranges of 50 to 200 % of labeled claims with r 2 near to 1. Developed method proved to be precise for inter and intra-day studies the %RSD values were < 2 , accuracy studies by standard addition at 80, 100 and 120% levels resulted in recoveries of standard near to 100%. The method was selective with no interferences from placebo; robustness of method was proved by no significant alteration in system suitability parameters. The LOD values for PHE, PAR, CAF and LEV were 0.13, 0.51, 0.05 and 0.05 and LOQ were 0.39, 1.53, 0.15 and 0.15 respectively. The study concluded a validated HPLC method for analysis of complex mixture consisting PHE, PAR, CAF and LEV in bulk, tablet and dissolution samples in simulated gastric fluid (SGF).

A quality-by-design eco-friendly UV-HPLC method for the determination of four drugs used to treat symptoms of common cold and COVID-19

“… Flow rate (mL/min.) Waste (g/run) Run time × flow rate 10 NEMI Eco-scale score Complex GAPI AGREE Reported HPLC method 16 5 to 30 diethyl-carbamazine 0.1 to 1 LVC diethylcarbamazine and LVC potassium dihydrogen orthophosphate buffer (pH: 3.2): acetonitrile (50:50 v/v) 6 1 6 66 Reported HPLC method 17 5–35 for all the drugs Salbutamol sulfate, Guaifenesin, and AMB potassium dihydrogen ortho-phosphate buffer and methanol (58:42 v/v), pH 4.5 7 1 7 70 Reported HPLC method 18 2.5–10 PHN, 250–750 PAR, 15–45 caffeine and 1.25–3.54 LVC PHN, PAR, LVC and caffeine Three steps gradient elution, 10 mM phosphate buffer (pH 3.3) and methanol 2–80% 18 1 18 67 Reported HPLC method 19 50–150% for all the drugs Ascorbic acid, PHN, PAR and LVC A gradient elution using phosphate buffer pH 4.0: Acetonitrile 23 1.5 34.5 …”

“…A combination of Salbutamol sulfate, Guaifenesin, and Ambroxol hydrochloride that are used for suppression of cough was assayed in combined tablet dosage form using HPLC 17 . HPLC–DAD method was reported for the analysis of a complex mixture consisting of phenylephrine hydrochloride, paracetamol, caffeine and levocetirizine 18 . Gradient RP-HPLC method was developed for the simultaneous estimation of ascorbic acid, phenylephrine HCl, paracetamol, levocetirizine HCl in tablet dosage form 19 .…”

Design and validation of analytical methods for quantitative determination of active ingredients in extemporal combined medicine in spray form

“…This method is widely used to determine each of the components of the dosage form. Thus, the HPLC method is proposed for the determination of diphenhydramine hydrochloride in monocomponent ready-made medicinal products [3,4] and biological fluids [5], phenylephrine hydrochloride [6], nitrofural and its metabolites [7], in multicomponent medicinal products -for the determination of phenylephrine hydrochloride in a mixture with anti-inflammatory [8] and anti-inflammatory and antihistamine drugs [9,10], in a combination of nitrofurazone with lidocaine hydrochloride [11] and others.…”