Abstract

A simple, precise, accurate, and reliable HPTLC method has been developed and validated for the analysis of EPE-Eperisone hydrochloride and PCM-Paracetamol in their combined dosage form. Identification and analysis were performed on 100 mm × 100 mm layer thickness 0.2 mm, precoated silica gel G60-F254 aluminum sheet, prewashed with methanol, and dried in an oven at 50°C for 5 min. Toluene : methanol : ethyl acetate : glacial acetic acid (4 : 3.5 : 2.5 : 0.05) (v/v/v/v) was used as mobile phase. Calibration plots were established showing the dependence of response (peak area) on the amount chromatographed. The validated calibration ranges were 200–700 ng/spot and 1300–4550 ng/spot for EPE and PCM with correlation coefficient (R2) 0.994 and 0.996, respectively. Average % recovery was between 98.61–100.94% and 99.18–100.57% for EPE and PCM, respectively. The spots were scanned at 248 nm in a reflectance mode. The proposed method was validated as per ICH guidelines and successfully applied to the estimation of EPE and PCM in their combined tablet dosage form.

Highlights

  • EPE is chemically (2RS)-1-(4-ethylphenyl)-2-methyl-3-(1-piperidinyl)propan-1-one and hydrochloride (1 : 1) (Figure 1(a)) [1, 2]

  • Eperisone HCl increases the blood supply to skeletal muscles; this action is noteworthy since a muscle contracture may compress the small blood vessels and induce an ischemia leading to release of pain stimulating compounds [3]

  • The present paper describes a simple, accurate, and precise method for simultaneous estimation of EPE and PCM in combined tablet dosage form by HPTLC method

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Summary

Introduction

EPE is chemically (2RS)-1-(4-ethylphenyl)-2-methyl-3-(1-piperidinyl)propan-1-one and hydrochloride (1 : 1) (Figure 1(a)) [1, 2]. Eperisone HCl is a centrally acting muscle relaxant; it acts at the level of spinal cord by blocking sodium channels and calcium channels. Eperisone HCl exerts its spinal reflex inhibitory action predominantly via a presynaptic inhibition of the transmitter release from the primary afferent endings via a combined action on voltage-gated sodium and calcium channels. EPE is official in Japanese pharmacopoeia [1]. Paracetamol is a weak inhibitor of PG-Prostaglandin synthesis of COX-1 and COX-2. Paracetamol is official in Japanese Pharmacopoeia [1], British Pharmacopoeia [5], United States Pharmacopoeia [6], and Indian Pharmacopoeia [7]

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