Author(s): Shivprasad Patil, Dr. Ajay Kshirsagar, Kartik Ade, Akash Bharkade, Madhav Bharkade, Ashish Birkalwar, Mahesh Chandolkar

Email(s): shivprasad2829@gmail.com

DOI: 10.52711/2231-5675.2023.00027   

Address: Shivprasad Patil*, Dr. Ajay Kshirsagar, Kartik Ade, Akash Bharkade, Madhav Bharkade, Ashish Birkalwar, Mahesh Chandolkar Department of Pharmaceutical Quality Assurance, D. K. Patil Institute of Pharmacy, Loha, Maharashtra, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 3,     Year - 2023


ABSTRACT:
The present study was undertaken to develop a spectrophotometric method for the determination of Posaconazole (PCZ) in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate, and precise UV-spectrophotometric method for the assay of PCZin bulk and marketed dosage forms. The validation of the developed method was carried out according to ICH guidelines concerning linearity, precision, accuracy, specificity, the limit of detection, and the limit of quantification. The diluent is aqueous methanol. Calibration curves were obtained in the concentration range of 04-20µg/ml for PCZ and with good correlation coefficients (R2=0.9981). The precisions of the new method for the drug were less than the maximum allowable limit (%RSD < 2.0) specified by the ICH. Therefore, the method was found to be accurate, reproducible, and sensitive for the analysis of PCZ in pharmaceutical dosage forms.


Cite this article:
Shivprasad Patil, Dr. Ajay Kshirsagar, Kartik Ade, Akash Bharkade, Madhav Bharkade, Ashish Birkalwar, Mahesh Chandolkar. Development and Validation of UV Spectroscopy Method for the Determination of Posaconazole in Bulk and Formulation. Asian Journal of Pharmaceutical Analysis. 2023; 13(3):171-4. doi: 10.52711/2231-5675.2023.00027

Cite(Electronic):
Shivprasad Patil, Dr. Ajay Kshirsagar, Kartik Ade, Akash Bharkade, Madhav Bharkade, Ashish Birkalwar, Mahesh Chandolkar. Development and Validation of UV Spectroscopy Method for the Determination of Posaconazole in Bulk and Formulation. Asian Journal of Pharmaceutical Analysis. 2023; 13(3):171-4. doi: 10.52711/2231-5675.2023.00027   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-3-3


REFERENCES:
1.    ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology. ICH Harmonised Tripartite Guidelines, 1994.
2.    Kim H, Likhari P, Lin C, Nomeir A. High-performance liquid chromatographic analysis of the anti-fungal agent SCH 56592 in dog serum. J Chromatogr. B 2000; 738:93- 98.
3.    Zhong W, Yang X, Tong W, Martin GE. Structural characterization of a novel degradant of the antifungal agent posaconazole. J Pharm Biomed Anal. 2012; 66:40-49.
4.    Ekiert RJ, Krzek J. Determination of azole antifungal medicines using zero-order and derivative UV spectrophotometry. Acta Pol Pharm. 2009; 66:19-24.
5.    Chhun S, Rey E, Tran A, Lortholar O, Pon G, Jullien V. Simultaneous quantification of voriconazole and posaconazole in human plasma by high-performance liquid chromatography with ultra-violet detection. J Chromatogr. B 2007; 852: 223-228.
6.    Kim H, Kumari P, Laughlin M, Hilbert M, Indelicato S, Lim J, Lin C, Nomeir A. Use of high-performance liquid chromatographic and microbiological analyses for evaluating the presence or absence of active metabolites of the antifungal posaconazole in human plasma. J Chromatogr. A 2003; 987: 243-248.
7.    Amitkumar J. Vyas, Brijesh H. Patel, Ashok B. Patel, Ajay I. Patel, Nilesh. K. Patel. A brief Review on Q-absorption Ratio Method in UV-Spectrophotometry. Asian Journal of Pharmaceutical Analysis. 2022; 12(4): 281-5.
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DOI: 10.5958/2231–5675 


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