Volume : 13, Issue : 02, February – 2026
Title:
DEVELOPMENT AND VALIDATION OF A RELIABLE, PRECISE AND STABILITY-INDICATING RP-HPLC METHOD FOR ESTIMATION OF OZENOXACIN IN PHARMACEUTICAL FORMULATIONS: A REVIEW
Authors :
Sakshi Dinkar Ambhore , Prof. Anjali Rathod
Abstract :
Analytical method development and validation are essential components of pharmaceutical quality control to ensure the safety, efficacy, and stability of drug products. Ozenoxacin is a non-fluorinated quinolone antibiotic widely used in topical pharmaceutical formulations for the treatment of bacterial skin infections. Accurate estimation of this drug in dosage forms is necessary to maintain product quality and meet regulatory requirements. Reverse Phase High- Performance Liquid Chromatography (RP-HPLC) has emerged as a preferred analytical technique due to its high sensitivity, precision, and ability to separate active pharmaceutical ingredients from degradation products and excipients.This review presents a comprehensive overview of the development and validation of a reliable, precise, and stability-indicating RP-HPLC method for the estimation of Ozenoxacin in pharmaceutical formulations. The review discusses key aspects of method development, including selection of chromatographic conditions, mobile phase optimization, and detection parameters. Emphasis is placed on validation parameters such as linearity, accuracy, precision, specificity, robustness, and sensitivity, in accordance with international regulatory guidelines. Additionally, the importance of forced degradation studies in establishing the stability- indicating nature of the method is highlighted. Overall, this review aims to provide useful insights for researchers and analysts involved in pharmaceutical analysis and quality control of Ozenoxacin formulations.
Keywords: Ozenoxacin; RP-HPLC; Stability-indicating method; Method validation; Pharmaceutical analysis
Cite This Article:
Please cite this article in press Sakshi Dinkar Ambhore et al., Development And Validation Of A Reliable, Precise And Stability-Indicating Rp-Hplc Method For Estimation Of Ozenoxacin In Pharmaceutical Formulations: A Review, Indo Am. J. P. Sci, 2026; 13(02).
REFERENCES:
1. Snyder LR, Kirkland JJ, Dolan JW. Introduction to modern liquid chromatography. 3rd ed. Hoboken: John Wiley & Sons; 2010.
2. Sethi PD. HPLC: Quantitative analysis of pharmaceutical formulations. New Delhi: CBS Publishers; 2001.
3. Andriole VT. The quinolones: past, present, and future. Clin Infect Dis. 2005;41(Suppl 2):S113–S119.
4. Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. J Pharm Anal. 2014;4(3):159–165.
5. Bakshi M, Singh S. Development of validated stability-indicating assay methods—critical review. J Pharm Biomed Anal. 2002;28(6):1011–1040.
6. International Council for Harmonisation (ICH). Validation of analytical procedures: Text and methodology Q2(R1). Geneva: ICH; 2005.
7. Leyden JJ, Del Rosso JQ. Ozenoxacin: A new topical quinolone for impetigo. Skin Therapy Lett. 2017;22(4):1–4.
8. Abadía M, Aramayona JJ, Carreras I. Pharmacological profile of ozenoxacin. Drugs R D. 2016;16(3):203–212.
9. Mitsuyama J, Sato Y, Izumiya H. In vitro antibacterial activity of ozenoxacin. Antimicrob Agents Chemother. 2015;59(6):3258–3265.
10. Blondeau JM. Fluoroquinolones: mechanism of action, classification, and development of resistance. Surv Ophthalmol. 2004;49(Suppl 2):S73–S78.
11. British Pharmacopoeia Commission. British Pharmacopoeia. London: The Stationery Office; 2022.
12. Sinko PJ. Martin’s physical pharmacy and pharmaceutical sciences. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2011.
13. Hooper DC. Mechanisms of quinolone action and resistance. Clin Infect Dis. 2001;32(Suppl 1):S9–S15.
14. Ahuja S, Dong MW. Handbook of pharmaceutical analysis by HPLC. Amsterdam: Elsevier; 2005.
15. United States Pharmacopeia Convention. USP–NF. Rockville: USP; 2023.
16. FDA. Guidance for industry: Analytical procedures and methods validation. Rockville: US FDA; 2015.
17. ICH. Q2(R1): Validation of analytical procedures. Geneva: ICH; 2005.
18. ICH. Stability testing of new drug substances and products Q1A(R2). Geneva: ICH; 2003.
19. Kazakevich Y, Lobrutto R. HPLC for pharmaceutical scientists. Hoboken: Wiley; 2007.
20. Meyer VR. Practical high-performance liquid chromatography. 5th ed. Hoboken: Wiley; 2010.
21. Dong MW. Modern HPLC for practicing scientists. Hoboken: Wiley; 2006.
22. Snyder LR, Kirkland JJ. Practical HPLC method development. 2nd ed. New York: Wiley; 1997.
23. Swartz ME, Krull IS. Analytical method development and validation. New York: Marcel Dekker; 2012.
24. Rao JR, Nageswara Rao R. Development and validation of analytical methods. J Pharm Biomed Anal. 2010;52(5):800–803.
25. Srivastava MM. High-performance liquid chromatography in pharmaceutical analysis. Pharm Rev. 2010;8(2):15–21.
26. Watson DG. Pharmaceutical analysis. 4th ed. London: Elsevier; 2012.
27. Willard HH, Merritt LL, Dean JA. Instrumental methods of analysis. 7th ed. New Delhi: CBS; 2004.
28. FDA. Reviewer guidance: Validation of chromatographic methods. Rockville: US FDA; 1994.
29. Chatwal GR, Anand SK. Instrumental methods of chemical analysis. 5th ed. Mumbai: Himalaya Publishing; 2014.
30. Blessy M, Singh S. Stability indicating assay methods. J Pharm Sci. 2013;102(1):1–13.
31. Ermer J, Miller JH. Method validation in pharmaceutical analysis. Weinheim: Wiley-VCH; 2005.
32. Gumustas M, Ozkan SA. Analytical and bioanalytical methods for quinolones. Crit Rev Anal Chem. 2017;47(1):1–18.
33. Singh S, Bakshi M. Stress testing of drug substances and products. Pharm Technol. 2000;24(2):1–14.
34. Reynolds DW, Facchine KL, Mullaney JF. Available guidance and best practices for conducting forced degradation studies. Pharm Technol. 2002;26(2):48–56.
35. ICH. Q1B: Photostability testing of new drug substances and products. Geneva: ICH; 1996.
36. Baertschi SW. Pharmaceutical stress testing. Boca Raton: CRC Press; 2005.
37. Singh R, Rehman Z. Current trends in forced degradation studies. J Pharm Educ Res. 2012;3(2):54–63.
38. Ribani M, Bottoli CB. Validation for chromatographic methods. Quim Nova. 2004;27(5):771–780.
39. Sharma BK. Instrumental methods of chemical analysis. 26th ed. Meerut: Goel Publishing; 2015.
40. ICH. Q6A: Specifications—test procedures and acceptance criteria. Geneva: ICH; 1999.
41. Swartz ME. Validation of HPLC methods. Pharm Technol. 2007;31(4):96–108.
42. Miller JN, Miller JC. Statistics and chemometrics for analytical chemistry. 6th ed. Harlow: Pearson; 2010.
43. AOAC. Official methods of analysis. 21st ed. Gaithersburg: AOAC; 2019.
44. USP <1225>. Validation of compendial procedures. Rockville: USP; 2022.
45. Vander Heyden Y, Nijhuis A. Guidance for robustness testing. J Pharm Biomed Anal. 2001;24(5–6):723–753.
46. Shabir GA. Validation of analytical methods. J Pharm Biomed Anal. 2003;31(1):11–19.
47. Sinko PJ. Pharmaceutical dosage forms and drug delivery. Philadelphia: Lippincott; 2012.
48. Lachman L, Lieberman HA. Pharmaceutical dosage forms: tablets. 2nd ed. New York: Marcel Dekker; 2009.
49. Allen LV, Ansel HC. Pharmaceutical calculations. 14th ed. Philadelphia: Wolters Kluwer; 2016.
50. Carstensen JT, Rhodes CT. Drug stability: principles and practices. 3rd ed. New York: Marcel Dekker; 2000.
51. Blessy M, Singh S. Role of stability-indicating methods in pharmaceutical analysis. Int J Pharm Sci Rev Res. 2012;14(2):34–40.