Analytical Method Development and Validation of Ornidazole in Bulk and Dosage Form

Abstract

In the given study, of an For the purpose of estimating ornidazole in bulk and dose form, an correct, exact, and specific approach has been established. by ultraviolet spectroscopy. Ornidazole belongs to the categories of antibacterial medications ( nitroimidazoles) also used to treat infections caused by anaerobic bacteria and protozoa. The procedure includes calculation of the absorbance of Ornidazole blend in Methanol water 1:9. The calibration curve method shows wavelength maxima for Ornidazole at 315 nm with Methanol water 1:9 in the wavelength having a correlation value of 0.999, between 2-28 g/ml. The mean recovery of Ornidazole was discovered to be in pharmaceutical dosage form 95.5%. Results of experiments were authenticated for Accuracy: correctness, exactness, precision, truthfulness, reliability, validity established adequately. The submission process is easy, quick, and appropriate for standard analysis. Statistics were used to validate the analysis\' findings, and recovery studies were administered as per the guidelines of ICH.

Introduction

III. RESULTS AND DISCUSSION

The accuracy, precision, repeatability, and specificity of the discovered approach have all been confirmed. Standard solutions had a nominal concentration of roughly 2-28 g/ml. With a linear correlation coefficient of 0.999 and a linear regression equation of y=0.3876x+0.0055, the proposed technique was confirmed to be linear (fig. 3). The range of concentrations where ornidazole may be relied upon was linear, ranging from 2-28 g/ml. The method's accuracy was demonstrated by the mean recovery, which was 95.54% (Table 9). RSD was less than 2%, as were the repeatability, intraday, interday precision, specificity, and accuracy. Using the suggested method, the potency of Ornidazole dosage forms was assessed. With the new analytical technique, the brand products satisfied the requirements. The reported method's capacity to provide data on specificity for their estimation in the With the new analytical technique, the brand products satisfied the requirements. The reported method's capacity to offer data on specificity for their estimation in the presence of formulation excipients is known as specificity. The absorbance obtained with the excipient mixture did not interact in any way with the standard absorbance. The percentage of ornidazole in the marketed product was determined to be 95.54% .

Conclusion

A simple and sensitive spectrophotometric method for Ornidazole as API and in pharmaceutical dosage form was developed. The new introduced method was found to be easy and reliable. The maximum absorbance for Ornidazole in methanol was found to be 315nm. The method was found to be progressive and behaves according to beers lamberts statue in concentration range of 2-28?g/ml for ornidazole. The correlation coefficient for Ornidazole was found to be 0.999. All the validation parameters were performed according to the I.C.H. guidelines. The method for the drug was found to be precise as %RSD for interday, intraday, repeatability was found to be less than 2. Table 11 : Summary of validation parameters S. No. Parameters Observation 1 Linearity and range 2-28?g/ml 2 Correlation value 0.999 3 Precision (%RSD) 3.1 Repeatability 1.2988 3.2 Interday 1.2988 3.3 Intraday 0.4242 3.4 % Recovery 95.5% 3.5 Specificity No Interference found 3.6 Limit of detection 3.10 3.7 Limit of quantification 9.40 4 % Assay 99.9%

References

[1] Mathieu C, Degrande E. Vildagliptin: a new oral treatment for type 2 diabetes mellitus. Vasc Health Risk Manag. 2008;4(6):1349-60 [2] Mentlein, R; Gallwitz, B; Schmidt, WE (1993). \"Dipeptidyl-peptidase IV hydrolyses gastric inhibitory polypeptide, glucagon-like peptide-1(7-36) amide, peptide histidine methionine and is responsible for their degradation in human serum\". European Journal of Biochemistry. 214 (3): 829–35 [3] Shweta B. Pednekar* and Sachi S. Kudchadkar, Development and validation of uv spectrophotometric method for the simultaneous estimation of levofloxacin hemihydrate and ornidazole in combined dosage form by absorbance ratio method, World Journal of Pharmaceutical Research, Volume 4, Issue 10, 2774-2785. 2015 [4] Supriya Ulhas Kubal* and Sachi S. Kudchadkar, Development and validation of a new uv spectrophotometric simultaneous equation method for estimation of cefixime trihydrate and ornidazole in a combined tablet dosage form, World Journal of Pharmaceutical Research, Volume 5, Issue 7, 1504-1515. 2016 [5] Harvey D, Analytical Chemistry 2.1, Chapter – Basic Tools Of Analytical Chemistry, DePauw University, 2020. [6] https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM070107. [7] Allen L. and Ansel H, Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadelphia: Lipincott Williams and Wilkins, 2014. [8] Aulton M. and Taylor K Aulton’s Pharmaceutics: The Design and Manufacture of Medicines, (4th ed.). Edinburgh: Churchill Livingstone,2013. [9] ICH I. Q2 (R1): Validation of analytical procedures: text and methodology. In International Conference on Harmonization, Geneva 2005 Nov. [10] Farrel Lisa Gauncar et al ; Development and validation of uv spectrophotometric method for determination of ofloxacin and ornidazole in combined dosage form using simultaneous equation method ; World Journal of Pharmaceutical Research ; Volume 6, Issue 8, 1026-1039. 2017.

Copyright

Copyright © 2023 Basant Kumar, Dr. Meenu Chaudhary. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.