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
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