Isoabsorptive Point Method for Simultaneous Determination of Paracetamol and Orphenadrine Citrate in Their Combined Pharmaceutical Dosage Forms

Amr A Mattar,Mahmoud Mohammed Mohammed Sebaay

doi:10.31487/j.gdt.2020.01.01

Abstract

A simple, specific, accurate and precise spectrophotometric method was settled for simultaneous determination of paracetamol and orphenadrine citrate in their pure form and in their pharmaceutical formulation. Isoabsorptive point technique has been used in simultaneous determination of both drugs without prior separation. Isoabsorptive point method parameters were validated according to ICH guidelines in which accuracy, precision, repeatability and robustness were found in accepted limits. Advantages and disadvantages of Isoabsorptive point were discussed and statistical comparison between the proposed method and the reference one was also performed.

Highlights

Paracetamol (PAR); N-(4-Hydroxyphenyl)acetamide (Figure 1) is related to a non-steroidal anti-inflammatory drugs (NSAID) which acts centrally and peripherally for treatment of non-inflammatory conditions in patients with gastric symptoms [1]
Two major problems were found during the analysis of PAR & Orphenadrine citrate (ORP) binary mixture; first, the overlapped spectra between the absorptivities of the drugs, and second, PAR, the major constituent in the dosage forms, had high absorbance, while ORP the minor component in the dosage forms, had low absorbance values
Sample enrichment technique was used in which the concentration of the minor component ORP in its binary mixture was increased to facilitate its determination [14]

Summary

Introduction

Paracetamol (PAR); N-(4-Hydroxyphenyl)acetamide (Figure 1) is related to a non-steroidal anti-inflammatory drugs (NSAID) which acts centrally and peripherally for treatment of non-inflammatory conditions in patients with gastric symptoms [1]. Orphenadrine citrate (ORP); (±)N,N-Dimethyl-2-[(o-methyl-a-phenylbenzyl) oxy] ethylamine citrate (Figure 1) is a skeletal muscle relaxant which acts centrally by depressing a specific neurons in the nervous system so that impulses of the somatic nerves can’t be generated [1]. The literature revealed that several methods have been carried out for the analysis of PAR and ORP in their mixture form or in their combination with other drugs. The aim of work is to develop a spectrophotometric method which is accurate, fast and non-complicated for determination of PAR & ORP combination without the interference of their additives or their excipients in pharmaceutical formulations

Methods

Results

Conclusion