Author(s): Abhishek Agrawal, Prem Kumar Bichala, Swapna Singh

Email(s): abhishek060688@gmail.com

DOI: 10.52711/2231-5675.2021.00016   

Address: Abhishek Agrawal*, Prem Kumar Bichala, Swapna Singh
School of Pharmaceutical Sciences, Pratap University, Jaipur, Rajasthan – 303104.
*Corresponding Author

Published In:   Volume - 11,      Issue - 2,     Year - 2021


ABSTRACT:
RP-HPLC method was developed for the determination for the validation of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. Chromatographic separation was performed on Develosil ODS HG-5 RP C18, 15x4.6mm, 5µm column, with mobile phase comprising of mixture of ACN: Methanol: Citric acid in the ratio of 50:45:5 v/v, at the flow rate 1.0ml/min and the detection was carried out at 296nm. The comprehensive forced stress testing has been carried out as per USP guidelines. The drug Nitazoxanide is subjected to synthetic Benzamide, and the drug Ofloxacin is subject to synthetic Fluoroquinolone. RP- HPLC method was developed to separate analyte from all other degradation peaks. The method was successfully validated as per ICH guidelines for the purpose of conducting studies of the analyte in quality control laboratory. The drug was subjected to different degradation conditions; it was found to be stable in all degradation conditions. The purposed HPLC method was found to be precise, specific, accurate, rapid and economical for the determination of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. The sample recoveries in all formulations were in good agreement with their respective label claims and this method can be used for routine analysis. The linearity range was found to be 0-50 (µg/ml) for Nitazoxanide and 0-50 (µg/ml) for Ofloxacin. Calibration curve was plotted and correlation co-efficient for the drugs found to be 0.999 and 0.997. Hence the results obtained were within the limits.


Cite this article:
Abhishek Agrawal, Prem Kumar Bichala, Swapna Singh. Simple and Sensitive Analytical Method Development and Validation of Nitazoxanide and Ofloxacin by RP- HPLC. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):84-6. doi: 10.52711/2231-5675.2021.00016

Cite(Electronic):
Abhishek Agrawal, Prem Kumar Bichala, Swapna Singh. Simple and Sensitive Analytical Method Development and Validation of Nitazoxanide and Ofloxacin by RP- HPLC. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):84-6. doi: 10.52711/2231-5675.2021.00016   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-2-6


REFERENCES:
1.    www.fda.gov/cder/drug/infopage/rosuvastatin/default. html
2.    https://pubchem.ncbi.nlm.nih.gov/compound/ofloxacin
3.    ICH, Text on Validation of Analytical Procedures, ICH – Q2A, International Conference on Harmonisation, IFPMA, Geneva, 1995; 2-3: A–1 to A–3.
4.    ICH, Validation of Analytical Procedures Methodology, ICH – Q2B, International Conference on Harmonisation, 1996; p1-3.
5.    ICH Guidelines, Q2 (R1) Validation of Analytical Procedures Text and Methodology, 2005; p1-6.
6.    Gadapa Nirupa1 and M Ravi RP-HPLC Analytical process Development and Validation for Simultaneous analysis of two Drugs, Nitazoxanide, Ofloxacin and its Pharmaceutical Dosage Forms International Journal of ChemTech Research CODEN (USA): IJCRGG ISSN: 0974-4290 Vol.4, No.2, pp775-783.
7.    Prashant D. Ghode, Sunil P. Pawar, Stability Novel HPLC technique development and validation for the coincident estimation of Azithromycin and Ofloxacin in bulk and its dosage forms.

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