Development And Validation of Stability Indicating Rp- Hplc Method for Simultaneuos Estimation of Cephalexin and Clavulanic Acid
Keywords:
Cephalexin, clavulanic acid, RP-HPLC, method development, stability study, force degradation and validationAbstract
The combined dosage form of cephalexin and clavulanic acid was tested using a stability- indicating RP-HPLC technique. The combined dosage form of cephalexin and clavulanic acid was tested using a stability-indicating rp-hplc technique.The measurement wavelength was found to be 228 nm. Linearity, accuracy, precision, robustness, LOD, and LOQ have all been verified for the approach. The concentration ranges of 62.5–187.5 μg/ml for clavulanic acid and 37.5–112.5 μg/ml for cephalexin were found to be linear. Using sodium dihydrogen phosphate monohydrate buffer (pH:5.0 with OPA): methanol in a 65:35% v/v ratio as the mobile phase, the rp-hplc approach showed better separation and asymmetry on an Intersil OCD C18 (250 x 4 mm, 4 μm) packed column at a flow rate of 1 ml/min. It was discovered that the retention times for cephalexin and clavulanic acid were 4.216 and 2.189 minutes, respectively. Drug products were subjected to oxidation, photolytic, thermal, acid, and base degradation during a stability study using forced degradation. Under the specified stress conditions, cephalexin and clavulanic acid were shown to degrade by 7–10%. The devised method, which can be employed for simultaneous estimation of cephalexin and clavulanic acid in their tablet dose form, was straightforward, precise, and specific
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Mohan H., Textbook of Pathology; 6th Edn; Jaypee Brothers Medical Publisher(P) LTD, New Delhi, 2010, pp 646.
Tripathi K.D., Essential of medical pharmacology; 7th Edn; Jaypee Brothers medical publisher(P) LTD, New Delhi, 2013,pp 579.
Narsu kumari k., rajiya sd, bhulakshmi a. (2019). Analytical method development and validation of cephalexin by rp-hplc method. Journal of emerging technologies and innovative research, 6(12), 696–699.
Vyas a, shukla s. S, patel r, pandey r, jain v, singh d, nagori b. P. Development and validation of spectrophotometric method for estimation of cephalexin in bulk and tablet dosage forms. Orient j chem 2011;27(1)
Jeswani, r. M., sinha, p. K., topagi, k. S., & damle, m. C. (2009). A validated stability indicating hptlc method for determination of cephalexin in bulk and pharmaceutical formulation. International journal of pharmtech research, 1(3), 527-536.
Sanjeevarani, a., rajesh, t., kumar, g. V., & haneef, m. A. Analytical method development and validation for simultaneous estimation of cephalexin and bromhexine hcl in pure and pharmaceutical dosage form by rp-hplc.
Rao, a. L., prasanthi, t., & spandana, u. S. (2017). Stability indicating rp-hplc method development and validation for the analysis of cephalexin and bromhexine in pharmaceutical dosage form. International journal of research in ayush and pharmaceutical sciences, 137-147.
Prasad, g. V., sravani, s., ishaq, b. M., madhu, m., munna, s., & gopinath, c. (2013). Development and validation of uv-spectrophotometric method for determination of cephalexin. Asian journal of research in chemistry, 6(5), 490-494.
Hussein, R. F., & Hammami, M. M. (2014). Determination of cephalexin level and stability in human plasma by fully validated rapid HPLC analysis. WJPPS, 3(12), 20- 31.
Gawande, V. T., Bothara, K. G., & Marathe, A. M. (2017). Stress studies and identification of degradation products of cephalexin using LC–PDA and LC– MS/MS. Chromatographia, 80(10), 1545-1552.
Eldin, A. B., Ismaiel, O. A., Hassan, W. A. F. F. A., & Shalaby, A. B. D. A. L. L. A. (2015). Development and validation of stability indicating green HPLC-UV method for determination of cephalexin in pharmaceutical dosage forms and human urine using micellar mobile phase. International Journal of Pharmacy and Pharmaceutical Sciences, 7(9), 122-127.
Khan, M. N., Ahmad, J., Jan, M. N., Gulab, H., & Idrees, M. (2016). Development and validation of a new spectrophotometric method for the determination of cephalexin monohydrate in pure form and pharmaceutical formulations. Journal of the Brazilian Chemical Society, 27(5), 912-918.
von Ahn, A., Dallegrave, A., & dos Santos, J. H. Z. (2022). Evaluation of the Cefalexin Drug Degradation Profile in Pharmaceutical Capsule Forms Based on Forced Degradation Studies. Chromatographia, 85(3), 263-279.
Fawaz, S., Merzouk, M., Barton, S., & Nabhani-Gebara, S. (2021). Stability of amoxicillin and clavulanic acid in separate containers for administration via a y- site. Drug design, development and therapy, 3979-3984.
Addotey, J. N., Awudzi, L., & Adosraku, R. K. (2014). Stability studies on reconstituted amoxicillin-clavulanic acid oral powder by HPLC method development and quantification. International Journal of Pharmaceutical Science and Practice, 3(1), 1- 12.
Atici, E. B., Yazar, Y., Ağtaş, Ç., Ridvanoğlu, N., & Karlığa, B. (2017). Development and validation of stability indicating HPLC methods for related substances and assay analyses of amoxicillin and potassium clavulanate mixtures. Journal of Pharmaceutical and Biomedical Analysis, 136, 1-9.
Zalewski, P., Cielecka-Piontek, J., & Paczkowska, M. (2014). Development and validation of stability-indicating HPLC method for simultaneous determination of meropenem and potassium clavulanate. Acta Pol Pharm, 71, 255-60.
International conference on Harmonization, Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products(Revision 2), CPMP/ICH Q1A(R2), 2003.
ICH, Q2B, Harmonized Tripartite Guideline, Validation, In: Proceedings of The International Convention On Quality For The Pharmaceutical Industry, Toronto, Canada, And September, 2002.
ICH, Validation of Analytical Procedures; Methodology, Q2 (R1), International Conference on Harmonization, IFPMA, Geneva 1996.
.
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