RP-UFLC Method for Estimation of Propafenone in Tablets

DOI:

https://doi.org/10.37285/ijpsn.2014.7.4.9

Authors

  • Sagar Suman Panda
  • Ravi Kumar B V V
  • Sasmita Kumari Acharjya
  • Kalyani Sahu

Abstract

A simple, precise and accurate RP-UFLC method was developed for determination of propafenone hydrochloride. Separation was carried on an Enable C18G column       (250 mm × 4.6 mm i.d., 5 μm) using methanol: 10 mM TBAHS (95:05, v/v) as mobile phase at flow rate of 1.0 ml/min in isocratic mode. The PDA detection wavelength was 247 nm. The retention time of propafenone was 2.692 min. The method was validated for linearity, specificity, precision, accuracy and robustness as per ICH. The method was linear in the concentration range of 10 – 250 µg/ml with correlation coefficients of 0.999. The LOD and LOQ were 4.5 µg/ml and 9.75 µg/ml, respectively. Average recoveries for recovery study were found to be in the range of 99.73-100.58. R.S.D. values for intraday, interday and system precision were found to be less than 2%. Specificity was established after forced degradation was performed by using HCl, NaOH, H2O2, thermal and UV radiation. The method was applied successfully for estimation propafenone in tablet formulation. 

 

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Propafenone, Reverse phase, Liquid chromatography, Forced degradation, Tablets

Downloads

Published

2014-11-30

How to Cite

1.
Panda SS, B V V RK, Acharjya SK, Sahu K. RP-UFLC Method for Estimation of Propafenone in Tablets. Scopus Indexed [Internet]. 2014 Nov. 30 [cited 2024 Dec. 21];7(4):2671-6. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/754

Issue

Section

Research Articles

References

Afshar M and Rouni M (2004). A rapid HPLC assay for the simultaneous determination of propafenone and its major metabolites in human serum. Anal Sci 20: 1307-1311.

Afshar M and Thorman W (2006). Validated capillary electrophoresis assay for the simultaneous enantioselective determination of propafenone and its major metabolites in biological samples. Electrophoresis 27: 1517-1525.

Ayad MM, Abdellatef HE, Hosny MM and Sharaf YA (2012). Conductometric titration method for determination of naftidrofuryl oxalate, propafenone HCl and sotalol HCl using silver nitrate. Eur J Chem 3: 332-336.

Ayad MM, Abdellatef HE, Hosny MM and Sharaf YA (2013). Application of 4-chloro-7-nitronezofuran for the analysis of propafenone and diltiazem hydrochlorides using kinetic spectrophotometric and spectrofluorimetric methods. Eur J Chem 4: 35-43.

Ayad M, Abdellatef H, Hosny M and Sharaf Y (2013). Utility of complexation reaction for the determination of some cardiovascular drugs. Asian J Pharm Clin Res 6: 92-102.

Bandarkar FS and Khattab IS (2010). Simultaneous estimation of glibenclamide, gliclazide and metformin hydrochloride from bulk and commercial products using a validated ultra fast liquid chromatography technique. J Liq Chromatogr Relat Technol 33: 1814-1830.

Bohm R, Ellrich R and Koytchev R (1995). Quantitation of R- and S-propafenone and of the main metabolite in plasma. Pharmazie 50: 542-545.

Bonato PS, de Abreu LR, de Gaitani CM, Lanchote VL and Bertucci C (2000). Enentioselective HPLC analysis of propafenone and its main metabolites using polysachharide and protein-based chiral stationary phase. Biomed Chromatogr 14: 227-233.

Brode E, Kripp U and Breckwoldt W (1988). HPLC determination of 5-hydroxypropafenone in plasma with electrochemical detection. Method Find Exp Clin Pharmacol 10: 319-329.

Buszewski B, Nowaczyk J, Liqor T, Olszowy P, Liqor M, Wasiniak B, Miekisch W, Schubert JK and Amann A (2009). Preparation and characterization of microporous fibers for sample preparation and LC-MS determination of drugs. J Sep Sci 32: 2448-2454.

Capucci A and Boriani G (1995). Propafenone in the treatment of cardiac arrhythmias. A risk benefit appraisal. Drug Safety 12:55-72.

Chan GLY, Axelson JE, Abbott FS, Kerr CR and McErlane KM (1987). Determination of propafenone in biological fluids by fused-silica capillary gas chromatogrsphy using electron-capture detection. J Chromatogr B Biomed Sci Appl 417: 295-308.

Chankvetadze B, Lomsadze K and Blaschke G (2001). Enantioseparation of antiarrythmic drugs propafenone and diprafenone, their metabolites and analogs by capillary electrophoresis. J Sep Sci 24: 795-801.

de Abreu LPR, Lanchote VL, Bertucci C, Cesarino EJ and Bonato PS (1999). Simultaneous determination of propafenone and 5-hydroxypropafenone enantiomers in plasma by chromatography on an amylase derived chiral stationary phase. J Pharm Biomed Anal 20: 209-216.

Develpment of ultra fast liquid chromatographic method for simultaneous determination of nitrendipine and carvone in skin diffusate samples. J Pharm Biomed Anal 50: 1080-1084.

Dhandapani B, Keerthi J, Naik MB, Lavanya L, Priyamvadha DL, Manjeera KK, Anusha BH and Baboo RVC (2010). Spectrophotometric estimation of propafenone in bulk drug and its pharmaceutical formulation. Int J Pharm Biomed Res 1: 49-53.

Flore Perez C, Juarez Olguin H, Flores Perez J, Ramirez Mendiola B and Bobadilla Chavez J (2005). A simple method to measure plasma levels of propafenone with fluorescence detection. Chromatographia 62: 373-377.

Gannu R, Yamasani VV, Yamasani SK, Palem CR, Voruganti S and Yamsani MR (2009) Develpment of ultra fast liquid chromatographic method for simultaneous determination of nitrendipine and carvone in skin diffusate samples. J Pharm Biomed Anal. 50: 1080–1084.

Harron DW and Brogden RN (1987). Propafenone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in treatment of arrhythmias. Drugs 34: 617-647.

Holzer W (2001). Unambiguous assignment of the 1H- and 13C-NMR spectra of propafenone and a thiophene analogue. Molecules 6: 796-802.

Hofmann U, Pecia M, Heinkele G, Dilger K, Kroemer K and Eichelbaum M (2000). Determination of propafenone and its phase I and phase II metabolites in plasma and urine by high-performance liquid chromatography-electrospray ionization mass spectrometry. J Chromatogr B Biomed Sci Appl 748: 113-123.

Hu X, Xu D, Liu S, Liu Z and Liu S (2009). Determination of propafenone hydrochloride by flow injection analysis coupled with resonance light scattering detection. Luminiscence 24: 79-83.

Huang MB, Li GL, Yang GS, Shi YH, Gao JJ and Liu XD (1997). Enantiomeric separation of aromatic amino alcohol drugs by chiral ion-pair chromatography on a silica gel plate. J Liq Chromatogr Relat Technol 20: 1507-1514.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005). Guideline on Validation of Analytical Procedures: Text and Methodology Q2 (R1), Harmonized Tripartite Guideline, Geneva, Switzerland.

Jadhav ML and Tambe SR (2013). Implementation of QbD approach to the analytical method development and validation for the estimation of propafenone hydrochloride in tablet dosage form. Chromatogr Res Int article ID. 676501:1-9.

Kern R (1994). Internally standardized simultaneous assay of propafenone and 5-hydroxypropafenone enantiomers in human plasma by means of high performance liquid chromatography. Method Find Exp Clinical Pharmacol 16: 203-210.

Koppel C, Tenczer J and Peixoto Menezes KM (1991). Formation of formaldehyde adducts from various drugs by use of methanol in a toxicological screening procedure with gas chromatography-mass spectrometry. J Chromatogr B Biomed Sci Appl 563: 73-81.

Kunicki PK, Paczkowski D and Sitkiewicz D (1992). High performance liquid chromatographic method for the simultaneous determination of propafenone and 5-hydroxypropafenone in human serum. Pol J Pharmacol Phar 44: 161-171.

Lamprecht G and Stoschitzky K (2009). Enantioselective analysis of R- and S-propafenone in plasma by HPLC applying column switching and liquid-liquid extraction. J Chromatogr B 877: 3489-3494.

Leoux MS and Maes RA (1991). Identification and determination of propafenone and its principal metabolites in human urine using capillary gas chromatography/mass spectrometry. Biol Mass Spectrom 20: 382-388.

Min JZ, Shimizu Y, Toyo’oka T, Inagaki S, Kikura Hanajiri R and Goda Y (2008). Simultaneous determination of 11 designated hallucinogenic phenethylamines by ultra-fast liquid chromatography with fluorescence detection. J Chromatogr B 873: 187-194.

Reimold SC, Maisel WH and Antman EM (1998). Propafenone for treatment of supraventricular tacchycardia and atrial fibrillation: a meta analysis. Am J Cardiol 82: 66-71.

Sorensen LK (2012). A liquid chromatography-electrospray tandem mass spectrometry method for the determination of antiarrythmic drugs and their metabolites in forensic whole blood samples. J Anal Toxicol 36:116-122.

Sun N, Wen J, Lu G, Hong Z, Fan G, Wu Y, Sheng C and Zhang W (2010). An ultra fast lc method for the determination of iodiconazole in microdialysis samples and its application in the calibration of laboratory-made linear probes. J Pharm Biomed Anal 51: 248-251.

Sweetman SC (2009). Martindale-The Complete Drug Reference, 36th ed., London: UK, Pharmaceutical Press 1379.

Tan W, Li Q, McKay G and Semple HA (1998). Identification and determination of phase I metabolites of propafenone in rat liver perfusate. J Pharm Biomed Anal 16: 991-1003.

Wu YJ, Ma MM and Zheng S (2004). Enantioselective assay of S(+) - and R(-) - propafenone in human urine by using RP-HPLC with pre-column chiral derivatization. J Zhejiang Univ Sci 5: 226-229.

Zhong D and Chen X (1999). Enantioselective determination of propafenone and its metabolites in human plasma by liquid chromatography-mass spectrometry. J Chromatogr B Biomed Sci Appl 721: 67-75.

Most read articles by the same author(s)