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Development and Validation of UPLC Method for Determination of Lamivudine Impurity Profile in Tablets
Corresponding Author(s) : Useni Reddy Mallu
Asian Journal of Chemistry,
Vol. 30 No. 5 (2018): Vol 30 Issue 5, 2018
Abstract
Lamivudine and its related impurities method separation was performed on Acquity UPLC BEH Phenyl C18 column 2.1 mm × 100 mm, 1.7 μm. The mobile phase consists of 0.025 mol L-1 ammonium acetate buffer pH 3.8 ± 0.05 and with gradient elution. Ammonium acetate buffer and methanol were used as diluent with 95:5 v/v ratio. The flow rate was 0.5 mL min-1 and the detection wavelength was 277 nm. Lamivudine was completely separated from salicylic acid impurity and unknown impurities. The linear range of lamivudine and salicylic acid was 0.12-4.51 and 0.20-3.38 ppm, respectively. The recovery of salicylic acid was found to be in between 80 to 120 % with RSD of 3.48 %. Method was robust against small variations in wavelength, pH, flow rate and column oven temperature. The RP-UPLC method is an ultra-fast, specific, precise, reproducible, accurate, rugged and robust, which may be useful for the routine estimation of lamivudine related substances in several pharmaceutical dosage forms.
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- C.M. Perry and Faulds, Drugs, 53, 657 (1997); https://doi.org/10.2165/00003495-199753040-00008.
- D. Fan and Stewart, J. Pharm. Biomed. Anal., 28, 903 (2002); https://doi.org/10.1016/S0731-7085(01)00708-7.
- J.J. Zheng, S.T. Wu and T.A. Emm, J. Chromatogr. A, 761, 195 (2001); https://doi.org/10.1016/S0378-4347(01)00332-2.
- S.A. Ozkan and B. Uslu, J. Liq. Chromatogr. Rel. Technol., 25, 1447 (2002); https://doi.org/10.1081/JLC-120004759.
- S. Verma, P. Mullick, M.S. Bhatt, N. Siddiqui, O. Alam, I. Bala and S.A. Khan, Acta Pol. Pharm., 67, 429 (2010).
- H.Y. Aboul-Enein and M.M. Hefnawy, Anal. Lett., 36, 2527 (2003); https://doi.org/10.1081/AL-120024340.
- M. Sarat, P. Murali Krishna and C. Rambabu, Int. J. Chemtech Res., 3, 939 (2012).
- Stability Testing: Photostability Testing of New Drug Substances and Products, Q1B, ICH Harmonised Tripartite Guideline, Current Step 4 version, dated 6 November (1996).
- United States Pharmacopeial Convention The United States Pharmacopeia, USP NF, vol. 29, p. 3050 (2005).
- http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
References
C.M. Perry and Faulds, Drugs, 53, 657 (1997); https://doi.org/10.2165/00003495-199753040-00008.
D. Fan and Stewart, J. Pharm. Biomed. Anal., 28, 903 (2002); https://doi.org/10.1016/S0731-7085(01)00708-7.
J.J. Zheng, S.T. Wu and T.A. Emm, J. Chromatogr. A, 761, 195 (2001); https://doi.org/10.1016/S0378-4347(01)00332-2.
S.A. Ozkan and B. Uslu, J. Liq. Chromatogr. Rel. Technol., 25, 1447 (2002); https://doi.org/10.1081/JLC-120004759.
S. Verma, P. Mullick, M.S. Bhatt, N. Siddiqui, O. Alam, I. Bala and S.A. Khan, Acta Pol. Pharm., 67, 429 (2010).
H.Y. Aboul-Enein and M.M. Hefnawy, Anal. Lett., 36, 2527 (2003); https://doi.org/10.1081/AL-120024340.
M. Sarat, P. Murali Krishna and C. Rambabu, Int. J. Chemtech Res., 3, 939 (2012).
Stability Testing: Photostability Testing of New Drug Substances and Products, Q1B, ICH Harmonised Tripartite Guideline, Current Step 4 version, dated 6 November (1996).
United States Pharmacopeial Convention The United States Pharmacopeia, USP NF, vol. 29, p. 3050 (2005).