Abstract
A gradient HPLC method coupled with diode array detection was developed and fully validated for the analysis of impurities in ropinirole using a Kromasil® C8 100 Å (250 × 4.6 mm, 5 μm) column with a flow rate 1.0 mL min−1 and detection at 250 nm. The mobile phase component A consisted of a mixture of 19.6 mM aqueous potassium dihydrogen phosphate–acetonitrile (98:2 v/v), pH adjusted to 7.0 with triethylamine and the mobile phase component B consisted of acetonitrile. The method was validated in terms of linearity, sensitivity, precision, accuracy and stability. The calibration curves for ropinirole and its five impurities showed good linearity (r > 0.998) within the calibration ranges tested. The intra- and inter-day RSD values were <3.9 %, while the relative percentage error E r was <5.8 % for all compounds. Accelerated stability studies performed under various stress conditions including oxidation, hydrolysis and UV light irradiation at 254 nm proved the selectivity of the procedure. Long-term stability studies performed on blistered tablets and under various conditions of heat and humidity indicate the presence of four of the studied impurities in less than 0.07 %. The method was applied successfully to the detection and determination of ropinirole impurities in pharmaceutical formulations.
Similar content being viewed by others
References
Müller T (2012) Transl Neurodegener 1:1–12
Jost WH, Angersbach D (2005) Drug Rev 11:253–272
Ravikumar K, Sridhar B (2006) Acta Cryst 622:265–267
Matheson AJ, Spencer CM (2000) Drugs 60:115–137
Maratos EC, Jackson MJ, Pearce RKB, Jenner P (2001) Mov Disord 16:631–641
Bogan RK, Fry JM, Schmidt MH, Carson SW, Ritchie SY (2006) Mayo Clin Proc 81:17–27
Swagzdis JE, Gifford R, Mco BA (1985) J Chromatogr 345:203–208
Ramji JV, Keogh IP, Blake TJ, Broom C, Chenery RJ, Citerone DR (1999) Xenobiotica 29:311–325
Beattie IG, Blake TJA (1989) J Chromatogr 474:123–138
Bhatt J, Jangid A, Shetty R, Shah B, Kambli S, Subbaiah G, Singh S (2006) J Pharm Biomed Anal 40:1202–1208
Bharathi DV, Jagadeesh B, Kumar SS, Lakshmi RN, Hotha KK (2009) Biomed Chromatogr 23:557–562
Onal A (2006) Chromatographia 64:459–461
Aydogmus Z (2008) Spectrochim Acta 70:69–78
Coufal P, Stulik K, Claeessens HA, Hardy MJ, Webb M (1999) J Chromatogr B 732:437–444
Coufal P, Stulık K, Claessens HA, Hardy MJ, Webb M (1998) J Chromatogr B 720:197–204
Krishnaiah C, Murthy MV, Reddy AR, Kumara R, Mukkantib K (2010) J Chin Chem Soc 57:348–355
Mustafa G, Baboota S, Ali J, Ahuja A (2012) J Pharm Innov 7:47–55
Parmar G, Sharma S, Singh K, Bansal G (2009) Chromatographia 69:199–206
Sahasrabuddhey B, Nautiyal R, Acharya H, Khyade S, Luthra PK, Deshpande PB (2007) J Pharm Biomed Anal 43:1587–1593
Zissis KD, Brereton RG, Escott R (1997) Analyst 122:1007–1033
Jancic-Stojanovic B, Malenovic A, Ivanovic D, Rakic T, Medenica M (2009) J Chromatogr A 1216:1263–1269
International conference on harmonisation (ICH) Topic Q3A, Impurities in new drug substances, June 2008, Revision 2, http://www.ich.org
USP 36/NF 31 (2013), pp. 5080
B’Hymer C (2006) J Chromatogr Sci 44:200–204
International conference on harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use, Topic Q2 (R1): validation of analytical procedures: text and methodology (2005). http://www.ich.org
ICH Harmonised tripartite guideline validation of analytical procedures: Text and Methodology, Topic Q2(R1), November 2005. http://www.ich.org
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Kakouris, A., Samara, V., Kalaskani, A. et al. Simultaneous Determination of Impurities in Ropinirole Tablets by an Improved HPLC Method Coupled with Diode Array Detection. Chromatographia 77, 447–457 (2014). https://doi.org/10.1007/s10337-013-2617-1
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10337-013-2617-1