VALIDATED REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE ESTIMATION OF TETRABENAZINE IN SELF-NANO EMULSIFYING DRUG DELIVERY SYSTEMS

Authors

  • SHASHI School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0002-4203-1476
  • NARENDRA KUMAR PANDEY School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0003-0821-7653
  • BIMLESH KUMAR School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0001-8072-5172
  • SACHIN KUMAR SINGH School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0003-3823-6572
  • DILEEP SINGH BAGHEL School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India
  • KALVATALA SUDHAKAR School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0002-1123-9864
  • SAURABH SINGH School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India

DOI:

https://doi.org/10.22159/ijap.2024v16i5.50489

Keywords:

Tetrabenazine, HPLC, Analytical method development, SNEDDS

Abstract

Objective: Self-Nano-Emulsifying Drug Delivery System (SNEDDS) of tetrabenazine (TBZ) was analysed using reverse-phase high-performance liquid chromatography.

Methods: Optimized chromatographic condition was consisted of Acetonitrile (ACN) and 0.1% v/v formic acid in the ratio of 90:10 as a mobile phase in isocratic mode at 25±1 °C. In this C-18 (250 mm×4.6 mm, 5 µm) column was used and absorbance was recorded at 283 nm.

Results: The compound was eluted at a flow rate of 1.0 ml/min and retention time (RT) was observed as 4.34±0.03 min. TBZ showed linearity over 2-10 µg/ml conc. and the value of regression was obtained as 0.9992. The developed method was found precise due to Percentage Relative Standard Deviation (%RSD) was less than 2 %. On the other hand, 0.31 and 0.96 were investigated value for Limit of Detection (LOD) and Limit of Quantification (LOQ), respectively.

Conclusion: The method adopted was found to be robust and can be apply for the determination of drug in different oil, surfactants and co-surfactants for the calculation of drug loading of pharmaceutical product formulation.

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References

Derangula VR, Pilli NR, Nadavala SK, Adireddy V, Inamadugu JK, Ponneri V. Liquid chromatography-tandem mass spectrometric assay for the determination of tetrabenazine and its active metabolites in human plasma: a pharmacokinetic study. Biomed Chromatogr. 2013;27(6):792-801. doi: 10.1002/bmc.2862, PMID 23339053.

Bourezg Z, Cartiser N, Ettouati L, Guillon J, Lacoudre A, Pinaud N. Structural elucidation of two photolytic degradation products of tetrabenazine. J Pharm Biomed Anal. 2014;91:138-43. doi: 10.1016/j.jpba.2013.12.032, PMID 24457996.

Hussar DA. New drugs: clevidipine butyrate, difluprednate, and tetrabenazine. J Am Pharm Assoc. 2008;48(6):815-21. doi: 10.1331/JAPhA.2008.08546, PMID 19019814.

Chen JJ, Ondo WG, Dashtipour K, Swope DM. Tetrabenazine for the treatment of hyperkinetic movement disorders: a review of the literature. Clin Ther. 2012;34(7):1487-504. doi: 10.1016/j.clinthera.2012.06.010, PMID 22749259.

Sharma S, Narang JK, Ali J, Baboota S. Synergistic antioxidant action of vitamin E and rutin SNEDDS in ameliorating oxidative stress in a Parkinson’s disease model. Nanotechnology. 2016;27(37):375101. doi: 10.1088/0957-4484/27/37/375101, PMID 27491690.

Mistry RB, Sheth NS. A review: self-emulsifying drug delivery system. Int J Pharm Pharm Sci. 2011;3:23-8. doi: 10.13040/ijpsr.0975-8232.4(12).4494-507.

Chen L, Lin X, Xu X, Chen Y, Li K, Fan X. Self-nano-emulsifying formulation of Sonchus oleraceus Linn for improved stability: implications for phenolics degradation under in vitro gastrointestinal digestion. J Funct Foods. 2019;53:28-35. doi: 10.1016/j.jff.2018.12.009.

Dash RN, Mohammed H, Humaira T, Reddy AV. Solid supersaturatable self-nanoemulsifying drug delivery systems for improved dissolution, absorption and pharmacodynamic effects of glipizide. J Drug Deliv Sci Technol. 2015;28:28-36. doi: 10.1016/j.jddst.2015.05.004.

Mehvar R, Jamali F, Watson MW, Skelton D. Direct injection high‐performance liquid chromatography of tetrabenazine and its metabolite in plasma of humans and rats. J Pharm Sci. 1986;75(10):1006-9. doi: 10.1002/jps.2600751021, PMID 3795018.

Ansari MJ, Alnakhli M, Al-Otaibi T, Al Meanazel OA, Anwer MK, Ahmed MM. Formulation and evaluation of self-nanoemulsifying drug delivery system of brigatinib: improvement of solubility, in vitro release, ex-vivo permeation and anticancer activity. J Drug Deliv Sci Technol. 2021;61:102204. doi: 10.1016/j.jddst.2020.102204.

Pandey NK, Singh SK, Ghosh D, Khursheed R, Kumar R, Kapoor B. Method development and validation for simultaneous estimation of glimepiride and simvastatin by using reversed phase high-performance liquid chromatography. Res J Pharm Technol. 2020;13(4):1655-9. doi: 10.5958/0974-360X.2020.00300.5.

Dagron S. Ethik Und R. Forsch Am Menschen, Die International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), H and b; 2014. p. 541-5. doi: 10.1007/978-3-642-35099-3_86.

Khursheed R, Singh SK, Kapoor B, Gulati M, Wadhwa S, Gupta S. Development and validation of RP-HPLC method for simultaneous determination of curcumin and quercetin in extracts, marketed formulations, and self-nanoemulsifying drug delivery system. Re: GEN Open. 2021;1(1):43-52. doi: 10.1089/regen.2021.0021.

Choudhury H, Gorain B, Karmakar S, Pal TK. Development and validation of RP-HPLC method: scope of application in the determination of oil solubility of paclitaxel. J Chromatogr Sci. 2014;52(1):68-74. doi: 10.1093/chromsci/bms206, PMID 23293041.

Kumar R, Kumar R, Khursheed R, Awasthi A, Khurana N, Singh SK. Development and validation of RP-HPLC method for estimation of fisetin in rat plasma. S Afr J Bot. 2021;140:284-9. doi: 10.1016/j.sajb.2020.05.010.

Kumar R, Kumar R, Khursheed R, Awasthi A, Ramanunny AK, Kaur J. Validated reverse phase-high-performance liquid chromatography method for estimation of fisetin in self-nanoemulsifying drug delivery system. Assay Drug Dev Technol. 2020;18(6):274-81. doi: 10.1089/adt.2020.983, PMID 32608988.

Chaudhari VS, Borkar RM, Murty US, Banerjee S. Analytical method development and validation of reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous quantifications of quercetin and piperine in dual-drug loaded nanostructured lipid carriers. J Pharm Biomed Anal. 2020;186:113325. doi: 10.1016/j.jpba.2020.113325, PMID 32380356.

Santhosh G, Nagasowjanya G, Ajitha A, Uma Y, Rao M. HPLC method development and validation: an overview. Life Science Informatics. 2014;4:274-80.

Khan AA, Akhtar S, Yadav Y, Atiya A, Alelwani W, Bannunah AM. Lopinavir-loaded self-nanoemulsifying drug delivery system for enhanced solubility: development, characterisation and caco-2 cell uptake. Curr Drug Deliv. 2023;20(10):1474-86. doi: 10.2174/1567201819666220817111054, PMID 35980056.

Kumar R, Khursheed R, Kumar R, Awasthi A, Sharma N, Khurana S. Self-nanoemulsifying drug delivery system of fisetin: formulation, optimization, characterization and cytotoxicity assessment. J Drug Deliv Sci Technol. 2019;54:101252. doi: 10.1016/j.jddst.2019.101252.

Shehata EM, Elnaggar YS, Galal S, Abdallah OY. Self-emulsifying phospholipid pre-concentrates (SEPPs) for improved oral delivery of the anti-cancer genistein: development, appraisal and ex-vivo intestinal permeation. Int J Pharm. 2016;511(2):745-56. doi: 10.1016/j.ijpharm.2016.07.078, PMID 27492016.

Khursheed R, Singh SK, Wadhwa S, Gulati M, Awasthi A, Kumar R. Exploring role of probiotics and ganoderma lucidum extract powder as solid carriers to solidify liquid self-nanoemulsifying delivery systems loaded with curcumin. Carbohydr Polym. 2020;250:116996. doi: 10.1016/j.carbpol.2020.116996, PMID 33049905.

Park JH, Kim DS, Mustapha O, Yousaf AM, Kim JS, Kim DW. Comparison of a revaprazan-loaded solid dispersion, solid SNEDDS and inclusion compound: physicochemical characterisation and pharmacokinetics. Colloids Surf B Biointerfaces. 2018;162:420-6. doi: 10.1016/j.colsurfb.2017.12.017, PMID 29248606.

Lakshmana Rao A, Prasanthi T, Anusha EL. RP-HPLC method development and validation for simultaneous estimation of linagliptin and empagliflozin. IND DRU. 2019;56(5):68-71. doi: 10.53879/id.56.05.11150.

Soni LK, Narsinghani T, Jain M. Development and validation of rp-hplc method for simultaneous estimation of metformin hydrochloride and repaglinide in tablet dosage form. J Liq Chromatogr Relat Technol. 2012;35(3):385-92. doi: 10.1080/10826076.2011.601492.

Published

07-09-2024

How to Cite

SHASHI, PANDEY, N. K., KUMAR, B., SINGH, S. K., BAGHEL, D. S., SUDHAKAR, K., & SINGH, S. (2024). VALIDATED REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE ESTIMATION OF TETRABENAZINE IN SELF-NANO EMULSIFYING DRUG DELIVERY SYSTEMS. International Journal of Applied Pharmaceutics, 16(5), 275–282. https://doi.org/10.22159/ijap.2024v16i5.50489

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