SIMULTANEOUS QUANTIFICATION OF BUPRENORPHINE HCL AND NALOXONE HCL BY VIERORDT'S METHOD

Authors

  • Dhanashree A. Mundhey Centre for Advanced Research and Innovation (CARIn), Zim Laboratories Ltd. B-21/22, MIDC Area, Kalmeshwar 441501 Dist. Nagpur (M. S.), India
  • Nidhi P. Sapkal Centre for Advanced Research and Innovation (CARIn),
  • Anwar S. Daud Centre for Advanced Research and Innovation (CARIn)

Keywords:

Nil, Simultaneous equation method, Buprenorphine HCl, Naloxone HCl

Abstract

Objective: Development of a simple, rapid and accurate vierordt's method or simultaneous equation (SE) method for the simultaneous estimation of Buprenorphine HCl (BU) and Naloxone HCl (NA) in bulk and pharmaceutical dosage form. The proposed method was validated according to the guidelines of the International Conference on Harmonization and the Association of Official Analytical Chemists International.

Methods: The method was based on the measurement of absorbance at two wavelengths 289.0 nm and 283.8 nm, λmax of BU and NA in methanol respectively.

Results: Calibration curves were linear in the concentration range of 40-200 µg ml-1 for BU and 40-260 µg ml-1 for NA. The mean recovery, limit of quantification (LOQ) and limit of detection (LOD) for BU were 98.91 %, 0.481 µg ml-1 and 0.158 µg ml-1 and for NA were 98.85 %, 1.283 µg ml-1 and 0.423 µg ml-1, respectively. The method was precise, with a relative standard deviation of less than 2.0 % for both drugs. For robustness, the factors analyzed did not significantly affect the quantification of BU and NA.

Conclusion: The proposed method can be successfully applied for simultaneous estimation of BU and NA in bulk and pharmaceutical dosage form.

 

Downloads

Download data is not yet available.

References

Buprenorphine Hydrochloride. United States Pharmacopoeia 30National Formulary 25 The Official Compendia of Standards United States Pharmacopeial Convention. 2007.

Drugbank Open Data Drug and Drug Target Database. Version 4.1. Available from: http://www.drugbank.ca/drugs/DB01183. [Article in Press]

Sweetman SC. Martindale the complete drug reference. 36th ed. London: Pharmaceutical Press; 2009.

Ash JE, Budavari S, O’Neill M, Smith A, Heckelman PE, Kinneary J. The Merck Index. 12th ed. USA: Chapman and Hall; 1996.

Heel RC, Brogden RN, TM Speight. Buprenorphine: a review of its pharmacological properties and therapeutic efficacy. Drugs 1979;17:81-110.

Hoskin PJ, Hanks GW. Opioid agonist-antagonist drugs in acute and chronic pain states. Drugs 1991;41:326-44.

Naloxone Hydrochloride. United States Pharmacopoeia 30–National Formulary 25. The Official Compendia of Standards. United States Pharmacopeial Convention; 2007.

Liao CL, Lee CY, Chiu TH. Development and validation of a stability indicating HPLC method for the determination of Buprenorphine in a transdermal patch. J Food Drug Anal 2008;16:1-7.

Amanlou M, Khosravian P, Souri E. Determination of Buprenorphine in raw material and pharmaceutical product using ion pair formation. Bull Korean Chem Soc 2007;28:183-7.

Yaqin LIU, Yonqlianq GAO. Determination of Naloxone hydrochloride nasal sprays and its related substances by HPLC. Pharm J Chin People's Liberation Army 2004;3:181–3.

Panchagnula R, Sharma P, Khandavilli S, Varma MVS. RP-HPLC method and its validation for the determination of naloxone from a novel transdermal formulation. II Farmaco 2004;59:839–42.

Mostafavi A, Abedi G, Jamshidi A. Development and validation of a HPLC method for the determination of Buprenorphine hydrochloride, Naloxone hydrochloride and Noroxymorphone in a tablet formulation. Talanta 2009;77:1415–9.

Damodar K, Bhogineni S, Ramanjaneyulu B. Analytical method development and validation for the simultaneous estimation of buprenorphine HCl & naloxone HCl in pharmaceutical dosage forms by RP-HPLC. Int J Pharm Biol Sci Arch 2011;2:1751–6.

Sun W, Qu S, Du Z. Hollow fiber liquid phase microextraction combined with ultra high-performance liquid chromatography-tandem mass spectrometry for the simultaneous determination of naloxone, buprenorphine and norbuprenorphine in human plasma. J Chromatogr B 2014;951-952:157-63.

Vora BN, Parmar RR, Nayak PP. Development and validation of the simultaneous UV spectrophotometric method for estimation of metoprolol succinate and olmesartan medoxomil in the tablet dosage form. Pharm Methods 2012;3:44-7.

Giriraj P, Sivakkumar T. Simultaneous estimation of durasteride and tamsulosin hydrochloride in tablet dosage form by vierordt’s method. Arabian J Chem 2013;67:1-6.

Giriraj P, Sivakkumar T. New simple spectrophotometric method for the simultaneous estimation of paracetamol and flupirtine maleate in pure and pharmaceutical dosage form. Int J Spectrosc 2014;1-6. doi.org/10.1155/2014/968420. [Article in Press]

Ultraviolet-visible reference spectra. Buprenorphine hydrochloride. Available from: http://www.pmda.go.jp/ english/pharmacopoeia/pdf/sixteenth_edition/JP. [Last accessed on 10 Jul 2015].

SIGMA Product Information. Buprenorphine hydrochloride. Available from: https://www.sigmaaldrich.com. [Last accessed on 10 Jul 2015].

Ultraviolet-visible reference spectra. Naloxone hydrochloride. Available from: http://www.pmda.go.jp/english/ pharma-copoeia/pdf/sixteenth_edition/JP. [Last accessed on 10 Jul 2015].

Beckett AH, Stenlake JB. Practical pharmaceutical chemistry. 4th ed. India (New Delhi): CBS Publishers and Distributers; 1988.

Jain A. Practical in modern pharmaceutical instrumental analysis. 1st ed. India (Pune) Nirali prakashan; 2011.

Jeffery GH, Bassett J, Mendham J. Vogel’s Textbook of Quantitative Chemical Analysis. 5th ed. New York: John Wiley and Sons Publishers; 1989.

Text on validation of analytical procedures: definitions and terminology (Q2A), Triplicate International Conference on Harmonization (ICH) text, ICH Tech coordination; 1994.

Text on validation of analytical procedures: definitions and terminology (Q2B), Triplicate International Conference on Harmonization (ICH) text, ICH Tech coordination; 1995.

AOAC. Association of Official Analytical Chemists. Official Methods of Analysis. 18th ed. Washington DC; 2005.

Elephant Care International. The elephant formulary: Buprenorphine hydrochloride. Available from: http://www.elephantcare.org/Drugs/buprenor.htm. [Last accessed on 10 Jul 2015].

Santa Cruz biotechnology. Product search: Naloxone Hydrochloride. Available from: http://www.scbt.com/ datasheet-203153-naloxone-hydrochloride.Html. [Last accessed on 10 Jul 2015].

Published

01-01-2016

How to Cite

Mundhey, D. A., N. P. Sapkal, and A. S. Daud. “SIMULTANEOUS QUANTIFICATION OF BUPRENORPHINE HCL AND NALOXONE HCL BY VIERORDT’S METHOD”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 8, no. 1, Jan. 2016, pp. 101-7, https://journals.innovareacademics.in/index.php/ijpps/article/view/8580.

Issue

Section

Original Article(s)