Tapentadol Assay Method (HPLC) on Purospher STAR RP-18 endcapped Column with UV Detection

Purospher® STAR RP-18 endcapped

Introduction

Tapentadol, commercially known as Nucynta, Palexia and Tapal is an opioid analgesic of the benzenoid class. It has a dual action mode, both as an agonist of the μ-opioid receptor and as a norepinephrine reuptake inhibitor (NRI). Tapentadol is the generic ingredient in branded drugs marketed in India by Lupin, IPCA, Aristo, MSN Laboratories, Cadila Pharmaceuticals Ltd. etc. This application note illustrate how Purospher® STAR RP-18 endcapped HPLC columns can be used to assay Tapentadol. Validation and verification data verify the appropriateness of this in-house developed method for the analysis of Tapentadol.

Tapentadol

Experimental Conditions
Column Purospher® STAR RP-18e (5µm) 250x4.6 mm Injection volume 10 µL
Detection UV @ 220 nm (analytical flow cell; 10 µL) Flow rate 1.0 mL/min
Buffer Dissolve 6.8 g potassium dihydrogen in 1000 mL.
Adjust with 6N KOH to pH 7.0 + 0.05.
Column temperature 30°C
Mobile phase A Buffer Pressure drop 135-145 bar
(1957-2102 psi)
Mobile phase B Mix buffer, acetonitrile and methanol 30:20:50 (v/v/v)    
Gradient See table    
Diluent Mobile phase B    
Standard Weigh 10 mg of standard in 100 mL of volumetric flask.
Dilute 1.0mL of this solution to 50 mL with mobile phase.
   
Sample Weigh 10 mg of sample in 10 mL of volumetric flask.
Dilute to the volume with mobile phase.
   

Retention time (min)
 

Gradient table

Time (min) A (%) B (%)
0 35 65
15 35 65
35 10 90
46 10 90
46.5 35 65
55 35 65

 

Retention Time Blank-Sample

 

Chromatographic Data (Standard Solution)
 

  Compound Retention Time (min) Tailing factor Theoretical plate
1 Tapentadol 13.5 1.2 11139

 

Validation and verification parameters
 

1.Specificity: Inject solution and determine the retention time of desired analyte in presence of other component like impurities and excipient.
    Retention Time (min) Tailing Factor
1 Tapentadol 13.5 1.2

 

3. Linearity, LOD & LOQ  
Concentration (ppm) Area
2 40461
10 270029
25 665244
50 1274679
100 2628412
160 4267148
200 5322353
240 6452346
300 8059420
LOQ (S/N ratio -10) 0.2 ppm
LOD (S/N-3) 0.06 ppm

 

2. Standard Repeatability (0.25 ppm)  
STD 1 41878
STD 2 41329
STD 3 41536
STD 4 41571
STD 5 41713
Mean 41605.4
Standard Deviation 205.1
RSD (%) 0.5

 

Retention Time Area

Materials

     
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