Development and optimization of RP-HPLC method for analysis of cefpodoxime proxetil impurity in pharmaceutical formulation
Keywords:
cefpodoxime acid, RP-HPLC, optimization, pharmaceutical formulationAbstract
The purpose of this research is to design and validate a unique, simple, and effective RP-HPLC analytical method using the QbD methodology. The QbD methodology not only confirms the method's robustness but also aids in the development of repeatable and reliable data. The goal of this work is to develop and validate a simple analytical RP-HPLC method for determining Cefpodoxime Impurity (Cefpodoxime Acid) in pharmaceutical formulations using the Analytical Quality by Design methodology (AQbd) in accordance with ICH Q8 guidelines. The Analytical Quality by Design technique was used in the proposed study. Cefpodoxime impurity (Cefpodoxime Acid) was chromatographically evaluated using an Inertsil C18 (5 m) column. The mobile phase was phosphate buffer and methanol pH 4.0 in the ratio of 60:40, which was driven onto the column at 0.8 ml/min using an isocratic elution protocol. 222 nm was discovered to be the detection wavelength for impurity estimation. Design expert 11 (Trial edition) software was used to investigate the effects of the mobile phase composition, flow rate, and pH. The analysis of cefpodoxime acid took 20 minutes to complete & at 15.6 minutes, the impurity was eluted.
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Acharya, D. R., & Patel, D. B. (2013). Development and Validation of RP-HPLC Method for Simultaneous Estimation of Cefpodoxime Proxetil and Dicloxacillin Sodium in Tablets. Indian Journal of Pharmaceutical Sciences, 75(1), 31–35. https://doi.org/10.4103/0250-474X.113538
Ansari, M. J., Ahmad, S., Kohli, K., Ali, J., & Khar, R. K. (2005). Stability-indicating HPTLC determination of curcumin in bulk drug and pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis, 39(1–2), 132–138. https://doi.org/10.1016/j.jpba.2005.03.021
Singh Bhupendra K. Nisha, (2019). Quality By Design : A Systematic Approach for the Analytical Method development. Journal of Drug Delivery & Therapeutics 9, 1006–1012.
Bala, I., Verma, S., Haque, A., & Singh, B. (2019). Determination of acceptable residual limit by using newly developed and validated RP-HPLC method for citalopram hydrobromide residues that swabbed from surfaces of pharmaceutical manufacturing equipment. International Journal of Drug Delivery Technology, 9(1), 10–14. https://doi.org/10.25258/ijddt.9.1.2
Bashir, L., Shoaib, M. H., Naz, S., Yousuf, R. I., Jabeen, S., Israr, F., & Siddiqui, F. (2017). Development and validation of HPLC method for the determination of Cefpodoxime Proxetil in human plasma. Pakistan Journal of Pharmaceutical Sciences, 30(5), 1603–1607. http://www.ncbi.nlm.nih.gov/pubmed/29084679
Council, I., Requirements, T., & Use, H. (2006). ICH Q3B (R2) Impurities in New Drug Products (ICH/v02062006). ICH Quality Guidelines, June.
Fukutsu, N., Kawasaki, T., Saito, K., & Nakazawa, H. (2006). Application of high-performance liquid chromatography hyphenated techniques for identification of degradation products of cefpodoxime proxetil. Journal of Chromatography A, 1129(2), 153–159. https://doi.org/10.1016/j.chroma.2006.06.102
Gandhi, S. V, Patil, U. P., & Patil, N. G. (2009). Simultaneous spectrophotometric determination of Cefpodoxime proxetil and potassium clavulanate. Hindustan Antibiotics Bulletin, 51(1–4), 24–28. http://www.ncbi.nlm.nih.gov/pubmed/21268556
Gedawy, A., Al-Salami, H., & Dass, C. R. (2019). Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin, and gliclazide. Journal of Food and Drug Analysis, 27(1), 315–322. https://doi.org/10.1016/j.jfda.2018.06.007
Jadhav, M. L., & Tambe, S. R. (2013). Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Propafenone Hydrochloride in Tablet Dosage Form. Chromatography Research International, 2013, 1–9. https://doi.org/10.1155/2013/676501
Jain, P., Bang, A., Chaudhari, A., & Surana, S. (2012). Validated stability-indicating high-performance thin-layer chromatographic method for estimation of cefpodoxime proxetil in bulk and pharmaceutical formulation according to International conference on harmonization guidelines. Journal of Pharmacy and Bioallied Sciences, 4(2), 101. https://doi.org/10.4103/0975-7406.94809
Jhanwar, B., Singh, B., Saini, G., & Verma, S. (2017). METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LEVOSULPIRIDE AND RABEPRAZOLE SODIUM: A NEW ANALYTICAL Q-ABSORBANCE RATIO APPROACH. Asian Journal of Pharmaceutical and Clinical Research, 10(16), 22. https://doi.org/10.22159/ajpcr.2017.v10s4.21331
Malathi, S., Dubey, R., & Venkatnarayanan, R. (2009). Simultaneous RP-HPLC estimation of cefpodoxime proxetil and clavulanic acid in tablets. Indian Journal of Pharmaceutical Sciences, 71(1), 102. https://doi.org/10.4103/0250-474X.51945
Mathew, C., Ajitha, M., & Sathesh Babu, P. R. (2013). Cefpodoxime Proxetil: A New Stability Indicating RP-HPLC Method. ISRN Chromatography, 2013, 1–8. https://doi.org/10.1155/2013/328157
Tomar, B., Sharma, A., Kumar, I., Jain, S., & Ahirrao, P. (2021). Development and Validation of the Analytical method for the estimation of a combination of 5-fluorouracil and Imiquimod by RP-HPLC. Research Journal of Pharmacy and Technology, 3313–3318. https://doi.org/10.52711/0974-360X.2021.00576
Vadera, N., Subramanian, G., & Musmade, P. (2007). Stability-indicating HPTLC determination of imatinib mesylate in bulk drug and pharmaceutical dosage form. Journal of Pharmaceutical and Biomedical Analysis, 43(2), 722–726. https://doi.org/10.1016/j.jpba.2006.07.022
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