Development and validation of RP-HPLC method for quantitative estimation of related substances in gatifloxacin drug substance

Alladi Devi  Sravanthi; Ponnuri Bharath; Peddi  Kiranmayi; Dittakavi Ramachandran

doi:10.62638/ZasMat1148

Autori

Alladi Devi Sravanthi Acharya Nagarjuna University, Department of Biochemistry, Nagarjuna Nagar, Guntur. Andhra Pradesh, India Autor
Ponnuri Bharath Acharya Nagarjuna University, Department of Chemistry, Nagarjuna Nagar, Guntur. Andhra Pradesh, India Autor
Peddi Kiranmayi Acharya Nagarjuna University, Department of Biochemistry, Nagarjuna Nagar, Guntur. Andhra Pradesh, India Autor
Dittakavi Ramachandran Acharya Nagarjuna University, Department of Chemistry, Nagarjuna Nagar, Guntur. Andhra Pradesh, India Autor

DOI:

https://doi.org/10.62638/ZasMat1148

Ključne reči:

Gatifloxacin, determination of related substances, liquid chromatography

Apstrakt

The analysis of improved RP-HPLC method for the separation and quantification of Gatifloxacin and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Zorbax Eclipse C18, 50 x 4.6 mm5µm and the mobile phase consists of two Channels A and B.Channel-A:0.1% Trifluoroacetic acid buffer and Channel-B:Acetonitrile. The flow rate is 1.0 ml/min. The column temperature was maintained at 35°C and sample temperature was maintained at 25°C, injection volume 10µLand wavelength fixed at 220nm UV-detection. The developed LC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline.

Reference

J.Gore, Z.Bryant, M.D.Stone, M.Nollmann, N.R.Cozzarelli (2006) Mechanochemical analysis of DNA gyrase using rotor bead tracking, Bustamante C Nature, 439, 100-104.

https://doi.org/10.1038/nature04319

A.H.Arteseros, J.Barbosa, O.R.Compan (2002) Nanotechnologies In Food And Agriculture, J. Chromatogr A, 945, 1-24.

V.Lorian (ed) (1996) Antibiotics in laboratory medicine, 4th edn. Williams and Wilkins, Baltimore, p. 591-592.

V.F.Samanidou, C.E.Demetriou (2003) Papadoyannis IN Anal, Bioanal Chem, 375, 623-629.

https://doi.org/10.1007/s00216-003-1749-9

S.Al-Dgither, S.N.Alvi, M.M.Hammami (2006), J.Pharm Biomed Anal, 41, 251-255.

https://doi.org/10.1016/j.jpba.2005.09.026

L.Kothapalli, A.D.Deshpande (2007). 69(4), Indian J Pharm Sci, 69, 525-528.

https://doi.org/10.4103/0250-474X.36938

W.Jiang, C.C.Guoa, P.Donga, Z.J.Chua, L.Wanga, W.Jiang (2008) A Validated, Specific Stability-Indicating RP-LC Method for Moxifloxacin and Its Related Substances, Luminescence, 23, 7-13.

I.U.Khan, S.N.Razzaq, I.Mariam, M.Ashfaq, S.S.Razzaq (2014) Stability-indicating RP-HPLC method for simultaneous determination of Gatifloxacin and flurbiprofen in binary combination., Quím. Nova, 37, 349-354.

https://doi.org/10.5935/0100-4042.20140058

M.I.Santoro, N.M.Kassab, A.K.Singh, E.R.Kedor-Hackmam (2006) Quantitative determination of Gatifloxacin, levofloxacin, lomefloxacin and pefloxacin fluoroquinolonic antibiotics in pharmaceutical preparations by high-performance liquid chromatography., J. Pharm.Biomed.Anal., 40(1), 179-184.

https://doi.org/10.1016/j.jpba.2005.06.018

P.Sonali, K.Lata, T.Asha, A.Deshpande (2006) Simultaneous spectrophotometric estimation of Gatifloxacin and ornidazole in tablet dosage form., Ind. J. Pharm. Sci., 68, 819-821.

https://doi.org/10.4103/0250-474X.31026

K.Venugopal, N.Ranendra (2005) New, simple and validated UV-spectrophotometric methods for the estimation of Gatifloxacin in bulk and formulations., Farmaco, 60, 906-912.

https://doi.org/10.1016/j.farmac.2005.08.010

ICH (1994) Text on validation of analytical procedures, Q2A (R1). International Conference on Harmonization, IFPMA, Geneva