1*Department of Pharmaceutical Analysis, Chennupati Indo-American School of Pharmacy, Jonnalagadda, Narasaraopet, Palnadu district, A.P., India. Email: chandana.mannepalli@gmail.com
2Department of Pharmaceutical Analysis, A. U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam. Email: akmpawar@andhrauniversity.edu.in
3Department of Pharmacy, Avanthi Institute of Pharmaceutical Sciences, Cherukupally, Vizianagaram, A.P India. Email: divya.molleti@gmail.com
4Department of Pharmaceutics, Vasanthidevi Patil Institute of Pharmacy, Kodoli-416114, Kolhapur, Maharashtra, India. Email: potti.lakshman@gmail.com
Background: A combination of moxifloxacin and loteprednol, formulated as ophthalmic eye drops at a concentration of 0.5% (w/v) for both drugs, is prescribed to address eye infections accompanied by inflammation. A literature review revealed the absence of reported methods for quantifying moxifloxacin and loteprednol. Therefore, the study expected to propose a straightforward and sensitive RP-HPLC method for determination in ophthalmic formulations.
Methods: Method development trials confirmed the effective separation of analytes on an Oyster BDS Premium C18 column (250 × 4.6, 5 µm) using acetonitrile and 0.1% aqueous ortho-phosphoric acid in 65:35 (v/v), pH 5.7, at 0.8 mL/min flowrate and 243 nm wavelength. This study enables the detection of moxifloxacin and loteprednol at retention times of 8.69 min and 7.65 min, respectively within 12 min run time. Calibration curves were linear within 12.5–75 µg/mL for both moxifloxacin and loteprednol. Notably, the method exhibited a highly sensitive detection limit of 0.095 µg/mL for the analytes.
Results: The procedure successfully meets all the validation criteria outlined in the guidelines, demonstrating its validity. It exhibits minimal degradation percentages in diverse stress scenarios, including acidic, basic, peroxide-induced, thermal, and UV light conditions. Furthermore, it efficiently distinguishes between various stress-induced degradation products, confirming its ability to indicate stability.
Conclusion: The method's suitability yields satisfactory assay percentages for both compounds suggest that the method was enough fit for quantification of moxifloxacin and loteprednol in bulk drug and ophthalmic drops formulations.
Keywords: Moxifloxacin, Loteprednol, HPLC method, Stress study, Ophthalmic solution
How to cite this article: Mannepalli C, Pawar KA, Divya M, Potti L. Stability Indicating HPLC-UV Method for the Simultaneous Quantification of Moxifloxacin and Loteprednol in Pure Drug and Eye Drop Formulations. Int J Drug Deliv Technol. 2026;16(13s): 815-823. DOI: 10.25258/ijddt.16.13s.89.
Source of support: Nil.
Conflict of interest: None