Modification of Extraction Methods on Determining Simeticone Suspension Using FTIR Method

Ida Musfiroh, Aliya Nur Hasanah, Gia A. Faradiba, Ida Ayumiati, Mutakin Mutakin, Muchtaridi Muchtaridi

Abstrak


Antacids dosage form are a class of drugs used to chemically bind and neutralize stomach acid. Simethicone is one of the antacids that works as an antiflatulant. In an effort to guarantee the quality of a preparation, a valid analysis method is needed that meets the validation parameters. This study aims to modified of extraction method of the simethicone content of suspension samples using the FTIR method. The methods include simethicone modification of extraction from suspension preparations with toluene solvents and hydrochloric acid (2:5) 3.35. Validation methods include: determination of precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ) at wave number 1261 cm-1 and determination of the content of samples of simethicone suspension. The results showed that linearity parameters with a correlation coefficient of 0.997 in a concentration range of 1000-10,000 ppm, precision with a value of KV <2%, LOD and LOQ, respectively 378.97 and 1250.59 ppm. The results of the determination of simethicone suspension samples indicate that this method met the requirements of the validation parameters.

Keywords: Validation, Simethicone, Infrared Spectrophotometry, antacid


Teks Lengkap:

PDF

Referensi


Rao G C., S., Sahoo N., K., Parhi R., Panigrahi N. Study On The Effectiveness Of Branded And Generic Antacid Suspension Forms. Journal of Pharmacy Research. Research Article. ISSN: 0974-6943. 2011, 4(3), 612-613

Flynn, C.A., Alnouti, Y., Reed, G.A., Quantification Of The Transporter Substrate Fexofenadine In Cell Lysates By Liquid Chromatography/Tandem Mass Spectrometry. Rapid Commun. Mass Spectrom. 2011. 25(16), 2361–2366.

Sapkal, N.P., Kilor, V.A., Shewale, B.D., Bhusari, K.P., Daud, A.S., Study of the complexation behaviour of fexofenadine with bcyclodextrin. Indian J. Pharm. Sci. 2010. 72 (3), 318–323.

Hassanuddin F., Kumar G.V., Haneef M.A. Validated High Performance Liquid Chromatography Method For Simultaneous Estimation Of Magaldrate and Simethicone In API and Tablet Dosage Form and Its Aplication To Forced Degradation Studies. International Journal of Pharmacy Review & Research. 2018, 8 (1); 12-18.

Benmassaoud A., Parent J., CAG Position Statement: The Impact of Simethicone on Endoscope Reprocessing. Publication. Canada: McGill University Health Center. Division of Gastroenterology. 2017.

United States Pharmacopeial Convention. Simethicone emulsion. United States Pharmacopeial Convention: Interim Revision Announcement Official 1 January 2014. Available at http://www.usp.org/sites/default/files/usp_pdf/EN/simethicone_emulsion.pdf. 2013.

Swartz M., E., Krull I., S. Handbook of Analytical Validation. CRC Press. Taylor & Francis Group. 2012.

Latha BM, Noorjahan MD, dan Madhkar A. A New RP-HPLC Method For The Simultaneous Estimation Of Magaldrate And Simethicone In Bulk And Tablet Dosage Form As Per Ich Guidelines. J Syn Natu Chem. 2018, 3(1): 31-34

Pienkowska MK. Size Exclusion Chromatography With Evaporative Light Scattering Detection As A Method For Speciation Analysis Of Polydimethylsiloxanes. III. Identification And Determination Of Dimeticone And Simeticone In Pharmaceutical Formulations. J Pharm Biomed Anal. 2012, 58: 200-207

Acunha CFS dan Santos JHZ. An Analytical Method for Quantifying Dimethicone in a 30% Simethicone Emulsion Using Gas Chromatography. Brazilian J. Anal. Chem. 2011 (6): 278-285.

Rohman A. Application of FTIR Spectroscopy for Quality Control in Pharmaceutical Products: a Review. Indonesian J. Pharm. 2012. 23 (1): 1-8.

Rohman A, Musfiroh A, dan Wijaya EG. Quantitative determination of simethicone in antacid suspension and chewable tablet using FTIR spectroscopy. Global J. Pharmacol. 2013. 7(3): 270-275.

Patel Rakesh, Patel Charmi, Rajesh. K. S; Quantitative Analytical applications of FTIR Spectroscopy in Pharmaceutical and Allied Areas; J. Adv. Pharm. Edu. & Res. 2014: 4(2): 145-57.

Riyanto, Nas S., W., Validation of Analytical Methods for Determination of Methamphetamine Using Fourier Transform Infrared (FTIR) Spectroscopy. Journal of Pharmacy and Biological Sciences. 2016, 11 (5); 51-59.

United Nations Office on Drugs and Crime (UNODC). Guidance for the validation of analytical methodology and calibration of equipment used for testing of illicit drugs in seized materials and biological specimens. United Nations Publication: New York. 2009.

Islam T, Ferdous S, Jain P, dan Reza HM. Method Development and Validation of Baclofen Mouth Dissolving Tablets by UV Spectroscopy. European J. of Appl. Sci. 2013. 5(1): 07-11.




DOI: https://doi.org/10.24198/ijpst.v6i3.22355

Refbacks

  • Saat ini tidak ada refbacks.


 Switch to English

Back to Top

View My Stats

Penerbit Universitas Padjadjaran

Jurnal ini terindeks di :

      

Creative Commons Attribution :

Creative Commons License
Indonesian Journal of Pharmaceutical Science and Technology by Universitas Padjadjaran is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Based on a work at http://jurnal.unpad.ac.id/ijpst/