Research Articles

2019  |  Vol: 5(5)  |  Issue: 5(September- October)  |  https://doi.org/10.31024/ajpp.2019.5.5.19
Quick and precise RP-HPLC method development for Tapentadol hydrochloride

Mamta Bishnoi1, Ankit Jain2*, Yashpaul Singla3, Birendra Shrivastava1

1Department of Pharmaceutics, School of Pharmaceutical Sciences, Jaipur National University, Jaipur (Raj.), India-302 017

2Pharmaceutics Research Projects Laboratory, Department of Pharmaceutical Sciences, Dr. Harisingh Gour Vishwavidyalaya, Sagar (M.P.), India - 470 003

3Department of Pharmaceutical Sciences, Guru Jambheshwar University of Science and Technology, Hisar (Haryana), India-125 001

Address for Corresponding Author:

Dr. Ankit Jain (M. Pharm. PhD),

Department of Pharmaceutical Sciences,

Dr. Harisingh Gour Vishwavidyalaya, Sagar (M.P.), India - 470 003

Abstract

Background: Tapentadol hydrochloride (TAP) is a novel opioid that binds and activates opioid receptor in the central nervous system to modify the approach our body interprets pain. It hasdual mechanism of action (mu opioid-receptor agonist and noradrenaline reuptake inhibitor), this feature makes it an attractivemember of opioid class. Objective: The aim of the present study was to develop and validate a simple, rapid, selective, sensitive, accurate and precise High Performance Liquid Chromatography (HPLC) with UV detection method to quantify TAP in rat plasma. Material and methods: Different analytical parameters, such as linearity, accuracy, precision, specificity with intentional degradation, limit of detection and limit of quantification (LOQ), were determined according to the ICH guidelines. The chromatographic separation of tapentadol hydrochloride was achieved with LC-2010 HT column using a mobile phase, potassium phosphate buffer: acetonitrile (50:50 v/v) at flow rate 1.0 ml/min. using a UV detector set at 272 nm with a continuous run up to 5 min. Plasma samples were processed using acetonitrile as precipitating agent to extract drug. Results and conclusion: The linearity for tapentadol hydrochloride was found to be 100-1000 ng/ml with regression coefficient (r2)> 0.9970. The recovery ranged from 98.9 to 100.8% for the drug with a relative standard deviation (%RSD) of <2%. Stability analysis revealed that the drugs remained stable for sufficienttime. The limit of quantification in plasma for tapentadol hydrochloride was found to be 10ng/ml. The mean recovery was obtained at 98.96%. The chromatographic runs were specific with no interfering peaks at the retention times of the analytes confirmed by the experiments. The method can be used to perform pharmacokinetic and bioequivalence studies in rat blood/serum.

Keywords: Tapentadol, Rat serum, Bio-analytical validation, HPLC

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