Development and Validation of Spectrophotometric Method for the Estimation of Enoxaparin sodium in marketed formulation
Simple, cost effective, precise and accurate UV-Spectrophotometric method for estimation of Enoxaparin sodium was developed and validated as per ICH guidelines. This Method involves solving of calibration curve based on measurement of absorbance wavelengths 234nm in 0.1 N HCl. The method obeys the Beer’s law in the concentration ranges 100-500µg/ml. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. % Recovery for both the drugs were in the range of 99.288 99.632% indicating excellent accuracy with percentage RSD Values less than 2. The method was precise, with a relative standard deviation of less than 2% for all tha validation parameters. Thus, method can be used for routine monitoring of drugs in industry for the assay of bulk drugs and commercials.
Keywords: UV-Spectrophotometric, Enoxaparin sodium, Validation, ICH guidelines
2. Buckley, M.M., Sorkin, E.M. Enoxaparin. Drugs 1992; 44:465–497.
4. Prasanthi Chengalva and Aruna Gundala, Development and validation of UV spectrometric method for quantitative determination of enoxaparin sodium in bulk and injectable, World Journal of Pharmaceutical Research, 2017; 6(16):1517-1523
5. Babu, Bujji N, Srinivasulu R, Raju, Ramesh R. Simultaneous analysis of RPHPLC Method development and validation of Enoxaparin sodium and Sitaglipitin drugs in pharmaceutical dosage form. J Pharm Res, 2011; 4:4029-36.
6. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Validation of analytical procedures; Text and methodology ICH Q2 (R1); 2005
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).