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Quantification of Prochlorperazine and Paracetamol Using High Performance Liquid Chromatography: Application to Tablets and Stability Studies
Corresponding Author(s) : Nowduri Annapurna
Asian Journal of Chemistry,
Vol. 31 No. 11 (2019): Vol 31 Issue 11
Abstract
This study reports a new stability indicating HPLC method using Spursil C18 column as stationary phase, and mixture of 0.1 M Na2HPO4 and methanol (50:50 v/v) as mobile phase for the chromatographic determination of paracetamol and prochlorperazine in tablets and in bulk form. The linearity range is 250-750 μg/mL for paracetamol and 2.5-7.5 μg/mL for prochlorperazine. The limit of detection values are 2.650 μg/mL for paracetamol and 0.175 μg/mL for prochlorperazine. The minor values of the relative standard deviation (≤ 2.0 %) as well as good percent assay values (nearer to 100 %) confirm the high precision and accuracy of the present method. From the degradation study chromatograms found that there was no interference from degradants when paracetamol and prochlorperazine are quantified in tablets through the proposed method. A good agreement between results obtained and labeled claim for the determination of paracetamol and prochlorperazine in tablet samples demonstrates that the proposed method is appropriate to quantify paracetamol and prochlorperazine in tablet formulations.
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- C. Hempel, W. Nörenberg, H. Sobottka, N. Urban, A. Nicke, W. Fischer and M. Schaefer, Neuropharmacol, 75, 365 (2013); https://doi.org/10.1016/j.neuropharm.2013.07.027.
- M.L.M. Lin, P.D. Robinson, J. Flank, L. Sung and L.L. Dupuis, Drug Saf., 39, 509 (2016); https://doi.org/10.1007/s40264-016-0398-9.
- D.H. Cunningham, G.J. Forrest, M. Soukop, N.L. Gilchrist, I.T. Calder and C.S. Mcardle, Br. Med. J., 291, 864 (1985); https://doi.org/10.1136/bmj.291.6499.864.
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- E.J. Giamarellos-Bourboulis, A. Spyridaki, A. Savva, M. Georgitsi, T. Tsaganos, M. Mouktaroudi, M. Raftogiannis, A. Antonopoulou, V. Papaziogas, F. Baziaka, K. Sereti, P. Christopoulos, A. Marioli, T. Kanni, P. Maravitsa, I. Pantelidou, K. Leventogiannis, P. Tsiaoussis, K. Lymberopoulou and I.M. Koutelidakis, J. Pharmacol. Sci., 124, 144 (2014); https://doi.org/10.1254/jphs.13133FP.
- C.A. Pierce and B. Voss, Ann. Pharmacother., 44, 489 (2010); https://doi.org/10.1345/aph.1M332.
- A. Gatti, E. Sabato, A.R. Di Paolo, M. Mammucari and A.F. Sabato. Clin. Drug. Investig., 30 Supl 2, 3 (2010).
- B. Hinz and K. Brune, Ann. Rheum. Dis., 71, 20 (2012); https://doi.org/10.1136/ard.2011.200087.
- D.M. Aronoff and E.G. Neilson, Am. J. Med., 111, 304 (2001). https://doi.org/10.1016/S0002-9343(01)00834-8.
- F. Antonaci, N. Ghiotto, S. Wu, E. Pucci and A. Costa, SpringerPlus, 5, Article No. 637 (2016); https://doi.org/10.1186/s40064-016-2211-8.
- J.J.Y. Ong and M. De Felice, Neurotherapeutics, 15, 274 (2018); https://doi.org/10.1007/s13311-017-0592-1.
- International Conference on Harmonization; Validation of Analytical Procedures: Text and Methodology, Q2 (R1), IFPMA, Geneva, Switzerland (2005).
- International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use Stability Testing of New Drugs Substance and Products Q1A (R2), Geneva, Switzerland (2003).
References
C. Hempel, W. Nörenberg, H. Sobottka, N. Urban, A. Nicke, W. Fischer and M. Schaefer, Neuropharmacol, 75, 365 (2013); https://doi.org/10.1016/j.neuropharm.2013.07.027.
M.L.M. Lin, P.D. Robinson, J. Flank, L. Sung and L.L. Dupuis, Drug Saf., 39, 509 (2016); https://doi.org/10.1007/s40264-016-0398-9.
D.H. Cunningham, G.J. Forrest, M. Soukop, N.L. Gilchrist, I.T. Calder and C.S. Mcardle, Br. Med. J., 291, 864 (1985); https://doi.org/10.1136/bmj.291.6499.864.
A.E. Patanwala, R. Amini, D.P. Hays and P. Rosen, J. Emerg. Med., 39, 330 (2010); https://doi.org/10.1016/j.jemermed.2009.08.060.
H.S. Smith, L.R. Cox and B.R. Smith, Ann. Palliat. Med., 1, 137 (2012); https://doi.org/10.3978/j.issn.2224-5820.2012.07.09.
E.J. Giamarellos-Bourboulis, A. Spyridaki, A. Savva, M. Georgitsi, T. Tsaganos, M. Mouktaroudi, M. Raftogiannis, A. Antonopoulou, V. Papaziogas, F. Baziaka, K. Sereti, P. Christopoulos, A. Marioli, T. Kanni, P. Maravitsa, I. Pantelidou, K. Leventogiannis, P. Tsiaoussis, K. Lymberopoulou and I.M. Koutelidakis, J. Pharmacol. Sci., 124, 144 (2014); https://doi.org/10.1254/jphs.13133FP.
C.A. Pierce and B. Voss, Ann. Pharmacother., 44, 489 (2010); https://doi.org/10.1345/aph.1M332.
A. Gatti, E. Sabato, A.R. Di Paolo, M. Mammucari and A.F. Sabato. Clin. Drug. Investig., 30 Supl 2, 3 (2010).
B. Hinz and K. Brune, Ann. Rheum. Dis., 71, 20 (2012); https://doi.org/10.1136/ard.2011.200087.
D.M. Aronoff and E.G. Neilson, Am. J. Med., 111, 304 (2001). https://doi.org/10.1016/S0002-9343(01)00834-8.
F. Antonaci, N. Ghiotto, S. Wu, E. Pucci and A. Costa, SpringerPlus, 5, Article No. 637 (2016); https://doi.org/10.1186/s40064-016-2211-8.
J.J.Y. Ong and M. De Felice, Neurotherapeutics, 15, 274 (2018); https://doi.org/10.1007/s13311-017-0592-1.
International Conference on Harmonization; Validation of Analytical Procedures: Text and Methodology, Q2 (R1), IFPMA, Geneva, Switzerland (2005).
International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use Stability Testing of New Drugs Substance and Products Q1A (R2), Geneva, Switzerland (2003).