Sai Prudhvi N, Venkateswarlu B. S.
Sai Prudhvi N1,2*, Venkateswarlu B. S.3
1Research Scholar, Vinayaka Missions College of Pharmacy, Salem, India.
2Department of Pharmaceutical Analysis, M.A.M College of Pharmacy, Guntur, India.
3Department of Pharmaceutics, Vinayaka Missions College of Pharmacy, Salem, India.
Volume - 13,
Issue - 12,
Year - 2020
Aim: The aim of the present study is to develop a high resolved and validated liquid chromatography method for the separation and quantification of pimozide and its related impurity A and B in bulk and pharmaceutical formulations. Materials and Methods: Separation of impurities and pimozide was achieved on Spherisorb ODS2 column (250mm x 4.6mm, 5µ) using mobile phase composition of methanol, acetonitrile and 0.1M sodium perchlorate in the ratio of 40:30:30 (v/v) at pH 6.1 as mobile phase at a flow rate of 0.8ml/min in isocratic condition. UV detection of the eluents was monitored at a wavelength of 240nm. Results: In the developed conditions, well resolved peaks were observed at a retention time of 7.0, 5.9 and 10.1 min for pimozide, Impurity A and B respectively. Calibration curve was plotted in the concentration range of 75-450 µg/ml for pimozide and 1-6µg/ml for impurity A and B with limit of detection of 2.4µg/mL, 0.016µg/mL and 0.025µg/mL for pimozide, impurity A and B respectively. Forced degradation study confirm that the method can be separate the known and unknown impurities of pimozide and the % degradation was found to be very less in all the stress conditions. Conclusion: The method can suitable for the identification and quantification of impurities A and B along with pimozide in bulk drug and formulations.
Cite this article:
Sai Prudhvi N, Venkateswarlu B. S. A Validated sensitive stability indicating HPLC method for the determination of pimozide and its related impurities in bulk Drug and Formulations. Research J. Pharm. and Tech. 2020; 13(12):6027-6034. doi: 10.5958/0974-360X.2020.01051.3
Sai Prudhvi N, Venkateswarlu B. S. A Validated sensitive stability indicating HPLC method for the determination of pimozide and its related impurities in bulk Drug and Formulations. Research J. Pharm. and Tech. 2020; 13(12):6027-6034. doi: 10.5958/0974-360X.2020.01051.3 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-12-66
1. Elizabeth Hogan. Nerves and Nerve Injuries, Pain, Treatment, Injury, Disease and Future Directions, Chapter 6 - The Treatment of Trigeminal Neuralgia, Elsevier academic press, Cambridge, Massachusetts, 2015; 2:81-97.
2. Kathryn N. Suh, Jay S. Keystone, Tropical Infectious Diseases: Principles, Pathogens and Practice (Third Edition), Chapter 140 - Delusional Parasitosis, Elsevier Academic Press, Cambridge, Massachusetts, 2011; 1066-1071.
3. Fibiger, H. C., D. A. Carter and A. G. Phillips. Decreased intracranial self-stimulation after neuroleptics or 6-hydroxydopamine: Evidence for mediation by motor deficits rather than by reduced reward. Psychopharmacology (Berlin). 1976; 47: 21-27, 1976.
4. Zarevics, P. and P. E, Setler. Simultaneous rate-independent assessment of intracranial self-stimulation: Evidence for the direct involvement of dopamine in brain-reinforcement mechanisms. Brain Res. 1979; 169: 499-512.
5. Anthony GP, Fredric G.LP. Effects of pimozide on positive and negative incentive contrast with rewarding brain stimulation. Pharmacol Biochem Behav. 1986; 24(6):1577-1582. [CrossRef]
6. Prachi Kabra LVG, Nargund M, Srinivasa Murthy. RP-HPLC method for estimation of an antipsychotic drug – pimozide. Asian J Pharm Clin Res. 2014; 7(2): 49-51.
7. Amal Mahmoud Abou Al Alamein, Lobna Abd El Aziz Hussien, Ekram Hany Mohamed. Univariate spectrophotometry and multivariate calibration: Stability-indicating analytical tools for the quantification of pimozide in bulk and pharmaceutical dosage form. Bull. Fac. Pharm. Cairo Univ, 2015; 53: 173–183. [CrossRef]
8. Sayanna Veeraiah T, Venkata Ramana Reddy Ch. Spectrophotometric determination of pimozide in pure and pharmaceutical forms using triphenyl methane dyes. Int. J. Chem. Pharm. Sci. 2014; 5(2): 105-111.
9. Lohita M, Shakirbasha S, Jaya Preethi P, Naresh D, Swetha K, Sunisitha B, Amrutha V. UV spectrophotometric determination of pimozide in bulk and tablet dosage forms. World J Pharm Pharm Sci. 2014; 2(9): 1046-1050.
10. Prachi Kabra M, Srinivasa Murthy LVG, Nargund. Development and validation of derivative spectrophotometric method for estimation of pimozide. Journal of Pharma Research 2016; 5(7): 168-170.
11. Manjula Devi AS and Ravi TK. Stability indicating HPTLC determination of pimozide in bulk and pharmaceutical dosage form. Der Pharmacia Lettre. 2013; 5(1): 182-187.
12. Kerbusch T, Desta Z, Soukhova NV, Thacker D, Flockhart DA. Sensitive assay for pimozide in human plasma using highperformance liquid chromatography with fluorescence detection: application to pharmacokinetic studies. J Chromatogr B Biomed Sci Appl. 1997; 694(1): 163-168. [CrossRef]
13. Sibel A, Özkan, Yalçin Özkan, Zühre Sentürk. Electrooxidation of pimozide and its differential pulse voltammetric and HPLC–EC determination. Analytica Chimica Acta. 2002; 453(2): 221–229. [CrossRef]
14. ICH Validation of analytical procedures: Text and Methodology Q2 (R1), 1994; 4: 1-13.
15. ICH Analytical Procedure Development and Revision of Q2(R1) Analytical Validation Q2(R2)/Q14, 2018.
16. Bikshal Babu Kasimala, Venkateswara Rao Anna and Useni Reddy Mallu. Stability-indicating reversed-phase HPLC method for the separation and estimation of related impurities of cilnidipine in pharmaceutical formulations. Indian Drugs. 2018; 55(12): 41-49.