The performance of derivate FTIR spectrophotometry method compared to colorimetry for tranexamic acid tablet content determination

Authors

  • Ilma Nugrahani School of Pharmacy ITB
  • Winni Nur Aulia School of Pharmacy

DOI:

https://doi.org/10.12928/pharmaciana.v8i1.8227

Keywords:

Keywords, FTIR, quantitative, derivate spectrum, tranexamic acid, colorimetry

Abstract

Recently, FTIR reported has been established as a direct content determination for some tablet dosage forms. In the method, infrared transmittance spectra was converted into the derivated absorbance form. In this present research, the method’s performance was investigated to quantified tranexamic acid in its tablet dosage form directly. The result then was compared to the colorimetry, which has been developed by another researcher. Correlations between the two methods were analyzed using t-test. The good linearity was shown at concentration range of 0.5 - 1.75% w/w at the wave number of NH group. Furthermore, the recovery, intra- and inter-day precision also fulfilled the validation requirement. Meanwhile, LOD and LOQ of the method were 0.0531%w/w and 0.1770%w/w. These methods were compared with colorimetry has been established before. Afterwards, the t-test proved no significant difference of content determination yielded, between these two methods. In conclusion, FTIR can be used for quantify the content of tranexamic tablet, more accurately than colorimetry, which has been developed before. Moreover, FTIR method also has advantages such as easier, simpler, faster and cheaper than the colorimetry method.  

References

Ahuja S, Dong M, 2005, Handbook of Pharmaceutical Analysis by HPLC, Elsevier Academic Press, North Carolina, 191-200.

Ansari TM, Raza A, Rehman AU, 2005, Spectrophotometric determination of tranexamic acid in pharmaceutical bulk and dosage form, Anal Sci, 1133-1135.

Arayne MS, Sultana N, Shiddiqui FA, Mirza, AZ, Zuberi, MH, 2008, Spectrophotometric techniques to determine tranexamic acid: Kinetic studies using ninhydrin and direct measuring using ferric chloride, J Mol Struct, 891, 475–480.

British Pharmacopoeia, 2009, British Pharmacopoeia Volume IV, Medicines and Healthcare Products Regulatory Agency (MHRA), London ;10185.

Departemen Kesehatan Republik Indonesia, 1995, Farmakope Indonesia edisi IV, Departemen Kesehatan Republik Indonesia, Jakarta, 74.

ICH, Harmonised Tripartite Guideline, 2005, Validation of Analytical Procedures: Text and Methodology, Geneva, IFPMA.

Najiyya A, 2015, Pengembangan dan Validasi Metode Penetapan Concentration Ketokonazol Menggunakan FTIR, skripsi sarjana, Institut Teknologi Bandung, 1-7.

Neal MJ, 2006, At a Glance FARMAKOLOGI MEDIS, Fifth ed. Jakarta: Penerbit Erlangga; 71.

Nugrahani I, Kirana C, 2016, Determination of thiamine HCl (vitamin b1) and pyridoxine HCl (vitamin b6) content in tablet by FTIR, Int J Appl Pharm, 8, 257-264.

Nugrahani I, Musaddah M., 2016, Development and validation analysis of acyclovir tablet content determination method using FTIR. Int J Appl Pharm, 8, 43-47.

Refat MS, Mohamed GG, Fathi A, 2010, Spectrophotometric Determination of Allopurinol Drug in Tablets: Spectroscopic Characterization of the Solid CT Complexes, Bull Korean Chem Soc, 31(6): 1535-1542.

Riyanto, 2014, Validasi and Verifikasi Metode Uji Sesuai dengan ISO/IEC 17025 Laboratorium Pengujian dan Kalibrasi, Deepublish, Yogyakarta, 20-63.

Skoog DA, West DM, Holler FJ, 2007, Principles of Instrumenal Analysis 6th edition.

Belmont: Thomson Higher Education, 430-480.

Smith BC, 1996, Fundamental Fourier Transform Infrared Spectroscopy, US: CRC Press, 139.

Sweetman SC, 2009, Martindale : The Complete Drug Reference 36th Edition, Chicago : Pharmaceutical Press, 552, 1080.

Tampubolon HB, Sumarlik E, Mochammad Y, Gunawan I, 2005, Densitometric Determination of Tranexamic Acid in Tablets: Validation of the Method, J Liq Chromatogr Related Technol, 28(20), 3243 – 3254.

Teli MS, Shukla S, Sawant SS, 2015, Estimation of Tranexamic Acid in Its Tablet and Bulk Formulation by RP-HPLC Method, World J Pharm Pharm Sci, 4(12), 1404-1415.

Downloads

Published

2018-06-02

Issue

Vol. 8 No. 1 (2018): Pharmaciana

Section

Analytical Pharmacy and Medicinal Chemistry

License

Authors who publish with Pharmaciana agree to the following terms:

  1. Authors retain copyright and grant the journal the right of first publication with the work simultaneously licensed under a Creative Commons Attribution License (CC BY-SA 4.0) that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal. 
  2. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
  3. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.