UV-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF BESIFLOXACIN HYDROCHLORIDE

  • Bijit Saha Shree S. K. Patel College of Pharmaceutical Education & Research, Ganpat University, Kherva, Gujarat, India http://orcid.org/0000-0002-5115-0362
  • Rakesh P Patel Shree S. K. Patel College of Pharmaceutical Education & Research, Ganpat University, Kherva, Gujarat, India
  • Tripti Halder Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India

Abstract

Objectives: The objective of the present investigation was to develope and validates a new, rapid, accurate high performance liquid chromatographic (HPLC) method for the quantification of Besifloxacin Hydrochloride.

Methods: Isocratic UV-HPLC separation was performed using a Zodiac C18 (150 X 4.6 mm) column, with 150 volume of Acetonitrile and 350 mL of Methanol in 500 mL buffer as mobile phase at a flow rate of 2 mL/min and UV detection at 295nm..

Results: The sample found stable for 24 hours in analyte solution and compatible with nylon filter. The Beer’s law plots were found to be linear over the concentration range 70% to 130% with a correlation coefficient (r2) 0.9999 in diluent, phosphate buffer and simulated tear media. The %RSD was found less than 2% shows good precision, acceptable accuracy and reproducibility of the new method for the determination of Besifloxacin Hydrochloride.

Conclusion: The method was validated as per the ICH guidelines. The method is accurate and can be applied for qualitative analysis of Besifloxacin Hydrochloride in bulk drug and in formulation.

 

Keywords: Besifloxacin hydrochloride, High performance liquid chromatographic, Stress testing, Validation, Linearity, Accuracy, Precision.

References

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Saha, B., R. P. Patel, and T. Halder. “UV-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF BESIFLOXACIN HYDROCHLORIDE”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 10, no. 5, May 2017, pp. 250-4, doi:10.22159/ajpcr.2017.v10i5.17456.
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