Development and Validation of Rp- HPLC Method for the Simultaneous Estimation of Tramadol Hydrochloride and Dicyclomine in Bulk and Pharmaceutical Formulation

Abstract

A simple, specific, accurate and precise reversed phase high pressure liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of tramadol hydrochloride (TRA) and dicyclomine (DCY) in bulk and tablet dosage form. Chromatography was carried on Phenomex Gemini C 18 column (4.6 x 250 mm, 5µ particle size) using mixture of methanol, acetonitrile and 0.1% triethylamine (TEA) pH 3.0 (adjusted with orthophophoric acid) in the ratio of 35:5:60 (v/v/v) respectively as a mobile phase. The flow rate 1.0mL min -1 and detection wavelength 275 nm was selected for the present study. The retention time of tramadol hydrochloride and dicyclomine were 4.13 min and 9.06 min respectively. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 50-300 μg mL -1 for tramadol hydrochloride and 10-60μg mL -1 for dicyclomine. The proposed method was validated with respect to linearity, precision, accuracy, specificity and robustness. The proposed method was found to be simple, rapid, accurate, precise and reproducible. Thus it can be applied for routine quality control analysis of tramadol hydrochloride and dicyclomine in tablet dosage form.

Interpol review of controlled substances 2016–2019

“…Tramadol: 2016 Potentiometric selective electrodes designed for the electrochemical determination of tramadol hydrochloride in bulk, Pharmaceutical formulations (also applied to plasma and urine) [ 487 ]; cyclic voltammetry for the determination of tramadol (also paracetamol and caffeine) [ 488 ]; RP-HPLC method for the simultaneous analysis of tramadol hydrochloride and dicyclomine in bulk and tablet dosage form [ 489 ]; all-solid-state ion selective electrode for the determination of Tramadol Hydrochloride [ 490 ]; electrochemical sensor fabricated based on a glassy carbon electrode for determination of tramadol in pharmaceutical and biological samples [ 491 ]; all solid state polymeric membrane electrode for analysis of tramadol hydrochloride in pharmaceutical formulations [ 492 ]; UV spectrophotometric method for simultaneous determination of paracetamol and tramadol in paracetamol-tramadol tablets [ 493 ]; formulation and dissolution kinetics study of hydrophilic matrix tablets with tramadol hydrochloride and different co-processed dry binders as possible controlled release formulations [ 494 ]; colorimetric method for estimation of tramadol hydrochloride in pure and tablet dosage forms [ 495 ]; predictive pharmacokinetics of tramadol hydrochloride floating tablets [ 496 ]; 2017 electrochemical imprinted sensor for determination of tramadol by combination of a functionalized multiwall carbon nanotubes and a thin molecularly imprinted film [ 497 ]; RP-HPLC method for simultaneous quantitation of tramadol and aceclofenac [ 498 ]; voltammetric determination of tramadol [ 499 ]; electrochemical determination of tramadol and paracetamol [ 500 ]; review article on tramadol [ 501 ]; electrochemical sensors for the determination of tramadol hydrochloride in pharmaceutical formulations [ 502 ]; glassy carbon electrode for determination of warfarin and tramadol in pharmaceutical compounds [ 503 ]; anisotropic (spherical/hexagon/cube) silver nanoparticle embedded magnetic carbon nanosphere as platform for designing of tramadol imprinted polymer [ 504 ]; synthesis of phosphorylated derivatives of cis-tramadol and analysis by IR, NMR (H-1, C-13, P-31), mass spectra, and C, H, N [ 505 ]; development of controlled release matrix tablets of tramadol [ 506 ]; enantiomeric separation of tramadol by LC with fluorescence detection [ 507 ]; 2018 LC-MS/MS Quantification of Tramadol and Gabapentin Utilizing Solid Phase Extraction [ 508 ]; liquid-liquid microextraction combined with GC-FID for the quantification of methadone and tramadol [ 509 ]; sensor for the determination of tramadol in pharmaceutical and biological samples [ 510 ]; 15-year overview of increasing tramadol utilization and the impact of tramadol classificat...…”

Different Innovative UV-spectroscopic Approaches for Simultaneous Assessment of Celecoxib and Tramadol Hydrochloride in Binary Mixture

“…A study of the relevant literature revealed a plethora of analytical methods for the evaluation of CXB and TMD both on their own and in combination dosage forms with other medications. These methodologies include UV Spectrophotometry, [10][11][12][13][14][15][16] HPLC, 15,[17][18][19][20][21][22][23][24][25][26][27][28] HPTLC, 18,[29][30][31][32] and LC-MS/MS. 33 On the other hand, the simultaneous measurement of CXB and TMD in the binary combination has not been reported by any analytical methods until this point.…”