RP-HPLC Method Development and Validation of Tapentadol Hydrochloride in Bulk and Pharmaceutical Formulations

Abstract

Objective: Tapentadol Hydrochloride was approved (November 2008) by the United States Food and Drug Administration for the relief of moderate to severe pain. It is an opioid analgesic, acts by dual mechanism as opioid receptor agonist and norepinephrine reuptake inhibitor. The present research work was aimed to develop an accurate, precise, and rapid RP-HPLC method and subsequently validates the method according to the International Conference on Harmonization (ICH) guidelines for the determination of Tapentadol Hydrochloride.
 Methods: Tapentadol Hydrochloride was analyzed by using High-Performance Liquid Chromatography. Better separation of the drug was achieved by using a Symmetry C18 column (150x4.6mm, 3.5μm) with the mobile phase consisted of a mixture of Orthophosphoric acid (0.1% of Orthophosphoric acid in HPLC water) and acetonitrile in the ratio of 30:70 v/v at a flow rate of 1 ml/min, and the detection was at the wavelength of 219nm using a PDA detector.
 Results: The retention time of Tapentadol Hydrochloride was found to be 3.747 ± 0.127 min. The method was found to be linear in the range of 10-200 ug/ml with a correlation coefficient (r2) of 0.9991. The LOD and LOQ of the method were calculated to be 0.1 and 1μg/ml respectively. The method precision and system precision was estimated and the results were calculated as % RSD values, which were found to be within the limits. Recovery of Tapentadol Hydrochloride was found to be 100.1%, which confirms the efficiency of the method.
 Conclusion: The developed RP-HPLC method was validated using standard ICH guidelines. The developed method can be used for the analysis of both tapentadol hydrochloride bulk and formulations.

Kinetic Spectrophotometric Determination of Tapentadol

“…A review of the analytical techniques described in the literature for evaluating Tap includes spectrophotometric methods such as first-order (228 nm) and second-order (235 nm) derivative methods (5) , UV and visible (Folin-ciocalteu reagent) analysis methods (6) , zero crossing at 242nm and 272nm (7) , UV at 271nm (8,9), In the study (10) , several methods were used, including UV light at 273.3 nm, Folin-Ciocalteu light at 494.6 nm, Orange-Red diazotize complex light at 414.6 nm, and ion pair with bromothymol Blue in Chloroform at 773.3 nm were all used. In addition, several chromatographic methods and techniques have been used to determine Tap in its pure form and for pharmaceutical doses, including HPLC with photodiode array detector (11) , HPLC with electrochemical detection (12) , RP-HPLC method (13,14) , HPTLC analysis (15) , LC-MS/MS technique (16) and RP-UFLC method (17) . In addition, the simultaneous determination of Tap includes Tap with aripiprazole (18) , Tap with paracetamol using two different first-order derivative methods (19) and a Q-spectrophotometric approach (20) and a nanographenemodified electrode as an electrochemical sensor.…”

Development and Validation of Ultraviolet and Reverse Phase-high Performance Liquid Chromatographic Method for Estimation of Cilnidipine

“…Limit of detection (LOD) and limit of quantification (LOQ) was used to determine the sensitivity of the method [13]. LOD and LOQ were calculated as…”

“…Robustness of the method was validated by three critical experimental variables such as mobile phase composition (methanol-water, 90:10, 90:11 and 90:9 v/v), wavelength (240, 241 and 242 nm), and flow velocity (1, 1.5 and 0.5 ml/min). The data was statistically analyzed and the results were represented in terms of mean, standard deviation, and % RSD [13].…”