Validasi Metode Analisis Matriks Patch Domperidon Maleat dengan Perbedaan Polimer Menggunakan Spektorfotometri UV-Vis

Shesanthi Citrariana(1*), Oktavia Indrati(2), Puspa Dwi Pratiwi(3), Ita Nurma Sari(4), Ari Wibowo(5)

(1) Muhammadiyah University of Palangkaraya
(2) Islamic University of Indonesia
(3) Adiwangsa University of Jambi
(4) Islamic University of Indonesia
(5) Islamic University of Indonesia
(*) Corresponding Author

Abstract

Uv-Vis spectrophotometry is an analytical method that can be used to determine the levels of domperidon maleate contained in transdermal patches with different polymers. The analysis method needs to be validated to prove that it can provide measurement results that match its designation. The purpose of this study is to prove that uv-vis spectrophotometry methods can provide the specificity, linearity, thoroughness, and precision that meet the requirements. In this study, linearity was known by calculating the r value on the curve of the relationship between levels and absorbance. Precision is obtained based on rsd value. Accuracy is calculated based on the return value. Selectiveity is known by means of identity confirmation that calculates the absorbance ratio at different wavelengths. The results showed that the method meets the requirements with a value of r=0.999; RSD precision results at a level of 10 ppm obtained RSD 0.236%. The accuracy values of 80%, 100%, and 120% in the matrix of transdermal domperidon maleate patches with PVA and PVP polymers respectively recovery was 99.50%, 101.15%, and 99.13%.. In the matrix of transdermal patches domperidon maleate with polymers HPMC and Na-CMC respectively recovery was 100.91%, 100.31%, and 100.67%. In the matrix of transdermal domperidon patches with HPMC and EC polymers respectively recovery was 98.00%, 98.00%, and 99.00%. The identity confirmation results on the transdermal domperidon patch matrix with PVA and PVP polymers, HPMC and Na-CMC, as well as HPMC and EC respectively have ratio value close to the standard solution with an average value of 0.800; 0,806; and 0.808. It can be concluded that the method of analyzing the levels of domperidone maleate in matrix of transdermal patches has qualified for good validity.

Keywords

domperidon maleate, Uv-Vis spectrophotometry, validation

Full Text:

PDF

References

Alarfaj, N.A., Mostafa, A.A., Al-Ghamdi, Z.A., 2013. Spectrophotometric Determination of Domperidone in its Pharmaceutical Formulation Through Charge Transfer Complexation Reactions. Asian J. Chem. 25, 7377–7380. https://doi.org/10.14233/ajchem.2013.14679

Astuti, I.Y., Martien, R., Nugroho, A.E., 2017. Validasi Metode Spektrofotometri Uv-Vis Untuk Studi Kelarutan Pentagamavunon-0 Di Dalam Pembawa Self-Nanoemulsifying Drug Delivery System 14, 10.

Garg, R.K., Singhvi, I., 2015. Uv Spectrophotometric Method Development and Validation for Quantitative Estimation of Nizatidine 2, 4.

Harmita, H., 2004. Petunjuk Pelaksanaan Validasi Metode Dan Cara Perhitungannya. Maj. Ilmu Kefarmasian 1, 117–135. https://doi.org/10.7454/psr.v1i3.3375

Hong, L., Han, D., Li, M.-X., Zhang, P., Liu, C.-G., 2017. Development and validation of an ultraviolet-visible spectrophotometric method for determination of phenylethyl resorcinol in new topical nanoemulsions. Int. J. Cosmet. Sci. 39, 337–343. https://doi.org/10.1111/ics.12381

Karanam, S.K., Alekhacharan, Soudamini, Madem, V., 2016. Method Development and Validation for the Estimation of Domperidone Maleate in Pharmaceutical Dosage Form by Uv- Spectrophotometry. Int. J. Chem. Pharm. Anal. 3, 1–9.

Nunes, P.S., Jesus, D.C., Bezerra, M.S., Souza, J.C.C., Silva, F.A., Serafini, M.R., Lima, B.S., Shanmugam, S., Albuquerque Junior, R.L.C., Araújo, A.A. de S., 2015. Validation of a Uv-Vis Spectrophotometric Method for the Determination of Usnic Acid /Collagen-Based Membranes. Sci. Plena 11. https://doi.org/10.14808/sci.plena.2015.094501

Prasanthi, T., 2017. Development and Validation of Uv Spectrophotom- Etric Method for Simultaneous Estimation of Omeprazole and Domperidone in Capsule Dosage Forms. Glob. J. Pharm. Pharm. Sci. 1. https://doi.org/10.19080/GJPPS.2017.01.555560

Swathi, B., Subramanyam, B., Dharmateja, B., Babu, M.H., Kiran, D., 2019. Development and Validation of New Analytical Method for the Simultaneouss Estimation of Pantoprazole and Domperidone by Uv- Spectrophotometry. Indo Am. J. Pharm. Res. 9, 8.

Tietje, C., Brouder, A. (Eds.), 2010. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, in: Handbook of Transnational Economic Governance Regimes. Brill | Nijhoff, pp. 1041–1053. https://doi.org/10.1163/ej.9789004163300.i-1081.897

Wisudyaningsih, B., 2012. Studi Preformulasi: Validasi Metode Spektrofotometri Ofloksasin Dalam Larutan Dapar Fosfat 9, 5.

Article Metrics

Abstract view(s): 563 time(s)
PDF: 994 time(s)

Refbacks

  • There are currently no refbacks.