Author(s): Sudhir K Sadul, A. Perumal, T. Somanath, Kalaivani

Email(s): sudhirsadul@rediffmail.com

DOI: 10.5958/0974-360X.2020.00853.7   

Address: Mr. Sudhir K Sadul1, Mr. A. Perumal2, Mr. T. Somanath3, Mrs. Kalaivani4
1Research Scholar (Chemistry), Vels University, Pallavaram, Chennai - 600043, Tamil Nadu, India.
2Former Professor (Chemistry), Vels University, Pallavaram, Chennai - 600043, Tamil Nadu, India.
3Professor (Chemistry), Vels University, Pallavaram, Chennai - 600043, Tamil Nadu, India.
4Head of the Department (Chemistry), Vels University, Pallavaram, Chennai - 600043, Tamil Nadu, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 10,     Year - 2020


ABSTRACT:
A PXRD quantitative method is developed for the Identification of Clobazam API[1] in Clobazam Oral Suspension 2.5mg/mL by using PXRD. The PXRD conditions for the Slow scan method developed for the identification of Clobazam API polymorph with a radiation source of Copper Ka1 ( ? = 1.54060A°). The Angular range was 3.5 to 45.0° 2? with the Voltage and Current set to 40kV & 40mA and a step size of 0.03° along with sample rotation of 5rpm. The scan type is Locked coupled, continuous with a high sensitive Lynxeye XET detector. The method developed was validated[2] for Specificity, Method Precision, Intermediate Precision and Robustness. The PXRD Method was found to be specific, Precise and robust for the identification of Clobazam API in Clobazam Oral suspension 2.5mg/mL by PXRD.


Cite this article:
Sudhir K Sadul, A. Perumal, T. Somanath, Kalaivani. Development and Validation of Method for the Estimation of Clobazam API in Clobazam Oral Suspension 2.5mg/mL by Power X-ray diffractometer (PXRD). Research J. Pharm. and Tech. 2020; 13(10):4851-4855. doi: 10.5958/0974-360X.2020.00853.7


REFERENCES:
1.    Hauptmann, K.H., Weber, K.-H., Zeile, K., Danneberg, P. and Giesemann, R.; South African Patent 68/0803; February 7,1968; assigned to Boehringerlngelheim GmbH, Germany.
2.    International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH harmonized tripartite guideline. Validation of Analytical
Procedures: Text and Methodology Q2(R1), step 4 (2005).
3.    Authors unspecified: Clobazam in treatment of refractory epilepsy: the Canadian experience. A retrospective study. Canadian Clobazam Cooperative Group. Epilepsia. 1991 May-Jun;32(3):407-16.
4.    Giarratano M, Standley K, Benbadis SR: Clobazam for treatment of epilepsy. Expert Opin Pharmacother. 2012 Feb;13(2):227-33. doi: 10.1517/14656566.2012.647686. Epub 2012 Jan 13.
5.    Wildin JD, Pleuvry BJ, Mawer GE, Onon T, Millington L: Respiratory and sedative effects of clobazam and clonazepam in volunteers. Br J Clin Pharmacol. 1990 Feb;29(2):169-77
6.    Wildin JD, Pleuvry BJ, Mawer GE, Onon T, Millington L: Respiratory and sedative effects of clobazam and clonazepam in volunteers. Br J Clin Pharmacol. 1990 Feb;29(2):169-77
7.    FDA, Guidance for Industry: Impurities in Drug Product, Draft Guidance, Center for Drug Evaluation and Research (CDER), 1998.

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