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

Email(s): sudhirsadul@rediffmail.com

DOI: 10.5958/0974-360X.2020.00940.3   

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 - 11,     Year - 2020


ABSTRACT:
A PXRD quantitative method is developed[1] for the Quantitation of % Tacrolimus crystalline in Tacrolimus Extended Release capsules using PXRD. The PXRD conditions for the Slow scan method developed for the estimation of % Tacrolimus crystalline, with a radiation source of Copper Ka1 (? = 1.54060A°). The Angular range was 9.65 to 10.80° 2?, with the Voltage and Current set to 40kV and 40mA and a step size of 0.02° along with sample rotation of 15rpm. The scan type is Locked coupled, continuous with a high sensitive Lynxeye XET detector. The developed method[2] was validated[3] for Specificity, Sensitivity (LOD and LOQ), Linearity, Accuracy and Robustness. The PXRD method is Linear with a concentration range of 0.2% to 1.0% with correlation coefficient of 0.996. The recoveries ranged between 83% - 110% for 0.2%, 0.6% and 1.0% levels. The XRD Method was found to be specific, linear, sensitive, accurate and robust for the estimation of % Tacrolimus Crystalline in Tacrolimus Extended Release capsules 0.5mg, 1mg and 5mg.


Cite this article:
Sudhir K Sadul, A. Perumal, T. Somanath, Kalaivani. Development and Validation of Method for the Estimation of Tacrolimus Crystalline API in Tacrolimus Extended Release Capsules 0.5mg, 1mg and 5mg by Power X-ray diffractometer (PXRD). Research J. Pharm. and Tech. 2020; 13(11):5375-5381. doi: 10.5958/0974-360X.2020.00940.3


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DOI: 10.5958/0974-360X 

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