HPTLC Method Development and Validation of Riluzole in Bulk and Pharmaceutical Dosage Form
Article Sidebar
Main Article Content
Abstract
Riluzole is used in the treatment for amyotrophic lateral sclerosis (ALS). The present work describes simple, precise and accurate HPTLC method for the determination of riluzole in bulk and its dosage form. Quantification of riluzole was carried out with Aluminum packed silica gel 60 F 254 precoated TLC plates as a stationary phase using a mixture of mobile phase consists of hexane: ethyl acetate in the ratio 1:1 v/v and in the absorbance/ reflectance mode at 222 nm using a CAMAG TLC scanner 3 with winCATS software version 1.4.3. The Rf value of riluzole was found to be 0.34 (±0.02). The proposed method has permitted the quantification of riluzole over the linearity range of 200-1000 ng/spot and its percentage recovery was found to 99.17%. The intraday and interday precisions were found to be 1.26% and 1.40%, respectively. The limit of
detection and the limit of quantification were found to be 18 ng/spot and 54 ng/spot respectively. The Coefficient of determination (r2) was 0.9992. The regression equation was found to be Y =9.8542C + 276.09. The accuracy and reliability of the proposed method was ascertained by evaluation various validation parameters like linearity, precision, accuracy and specificity according to ICH guidelines. The proposed method was analysed with more formulation units on a single plate and provided a faster and cost effective quality control tool for routine analysis of riluzole in bulk and its dosage form. The excipients in the commercial tablet preparation did n’t interfere in the method.
Keywords: Riluzole, ALS, HPTLC, densitometric evaluation, ICH guidelines, method development and validation
E-mail: swamilingam@gmail.com
Article Details
Copyright Transfer Statement
The copyright of this article is transferred to Current Applied Science and Technology journal with effect if and when the article is accepted for publication. The copyright transfer covers the exclusive right to reproduce and distribute the article, including reprints, translations, photographic reproductions, electronic form (offline, online) or any other reproductions of similar nature.
The author warrants that this contribution is original and that he/she has full power to make this grant. The author signs for and accepts responsibility for releasing this material on behalf of any and all co-authors.
Here is the link for download: Copyright transfer form.pdf
References
[2] Saminathan, J. and Vetrichelvan, T., 2011. Validation of UV spectrophotometric method for determination of riluzole in pharmaceutical dosage form, International Journal of ChemTech Research, 3(2), 560-564.
[3] Maltese, A., Maugeri, F., Drago, F. and Bucolo, C., 2005. Simple determination of riluzole in rat brain by high-performance liquid chromatography and spectrophotometric detection,Journal of Chromatography B, 817(2), 331-334.
[4] Colovic, M., Zennaro, E. and Caccia, S., 2004. Liquid chromatographic assay for riluzole in mouse plasma and central nervous system tissues, Journal of Chromatography B, 803(2),305-309.
[5] Van Kan, H.J.M., Spieksma, M., Groeneveld, G.J., Sastre Toraño, J., van den Berg, L.H. and Guchelaar, H.J., 2004. A validated HPLC assay to monitor riluzole plasma or serum concentrations in patients with amyotrophic lateral sclerosis, Biomedical chromatography,18(9), 723-726.
[6] Zhang, H-W., Liu, G-Y., Wang, W-Q., Jiang, G-P. and Ou, N., 2006. Determination of riluzole in human plasma by RP-HPLC with solid phase extraction method, Chinese Journal of Pharmaceutical Analysis, 26(3), 298-300.
[7] Wen, Y., Mo, Y. and Ma, C., 2005. Determination of the riluzole concentration in blood plasma by RP-HPLC, China Pharmacy, 3(17), 203-205.
[8] SivaKumari, K., Satyanarayana, B., Nageswari, A. and Shiva R., 2009. Development and validation of a novel stability-indicating LC method for the determination of riluzole in bulk drug and tablets, Chromatographia, 69, 513-517.
[9] Sreekanth, N., Bahlul Z.A., Babu R., C. and Mukkanti, K., 2011. An improved stabilityindicating HPLC method for riluzole hydrochloride in bulk and pharmaceutical dosage forms, Int. J. Pharm Biomed Res., 2(1), 48-55.
[10] Lothar, P., 2010. RP-HPLC and HPTLC methods for the estimation of riluzole in tablet dosage form, IJBR, 1(3), 124-127.
[11] Tian, Z., Zu, J. and Pei, F., 2009. Determination of riluzole by GC, Chinese Pharmaceutical Affairs, 022.
[12] Sharma, M.C., Sharma, S. and Sharma, A.D., 2011. Validation of riluzole by densitometry application, Journal of Pharmacy Research, 4(5), 1545-1547.
[13] ICH Steering committee, 2001. International conference on harmonization of technical requirements for registration of pharmaceutical for human use. Validation of Analytical Procedures: Text and Methodology, Q2 (R1), Geneva, Switzerland.