Development and Validation of a RP-HPLC Method for the Simultaneous estimation of Amoxicillin, Omeprazole and Tinidazole in fixed dose combinations
New liquid chromatographic technique was established for the simultaneous estimation of tinidazole, omeprazole and amoxicillin in the fixed dose combination (HP-KIT by Sun Pharma). RP-HPLC elution has performed by using the Phenomenex Luna column (250 mm x 4.6 mm) having internal diameter and the packing material of size 5µm) in isocratic mobile phase of solution A: acetonitrile at a ratio of 80:20 v/v (Solution A consists of Buffer: Acetonitrile: Methanol: Triethylamine in the ratios of 68:22:10:0.01 respectively). The selected flow rate was kept as 1 ml/min and selected wavelength was 230 nm was for detection of the drugs in UV detector. As per the ICH guidelines, the method validation was carried out. Moreover, the different parameters of method such as precision, specificity, linearity, robustness and accuracy were established. The time of retention for the tinidazole, amoxicillin, and omeprazole were 4.021 2.324, and 7.332 minutes respectively. The RP-HPLC approach was robust and accurate, so it is appropriate for repetitive assay of drugs and quality control. This method is effectively used for the assessment of marketable dosage form preparation.
Keywords: RP-HPLC, Amoxicillin, Tinidazole, Omeprazole, Method Development, Method Validation.
2. Ariane P, Rafael N, Bruno R, Marcos AS. Fabio S. Murakami Cruz Pereira Valente Silva Development and validation of a RP-HPLC method to quantify omeprazole in delayed release tablets, J of Liquid Chromatography and Related Technologies 2007; 30(1):113-21. https://doi.org/10.1080/10826070601034485
3. Darwish KM, Salama I, Mostafa S, El-Sadek M. RP-HPLC/pre-column derivatization for analysis of omeprazole, tinidazole, doxycycline and clarithromycin, J Chromatogr Sci 2013; 51(6):566-76. https://doi.org/10.1093/chromsci/bms167
4. Pasha K, Ali A, Bana S, Humair S, J. Reverse phase-HPLC method for the analysis of tinidazole in pharmaceutical dosage form & bulk drug, J Int Pharm Sci Acta Pharm 2010; 2(2):46-7.
5. Sneha JK, Nirav PB, Parag PR, Nikita PN, Hemant DT, Iosr. Development and validation of stability indicating method for simultaneous estimation of ciprofloxacin HCl and tinidazole using RP-UPLC method, J Acta Pharm 2012; 2(5):12-9. https://doi.org/10.9790/3013-25401219
6. Pasha K, Ali A, Bana S, Humair S, Reverse-phase-HPLC method for the analysis of tinidazole in pharmaceutical dosage form & bulk drug, J Int Pharm Sci Acta Pharm 2010; 2(2):46-7.
7. Beg, S., Kohli, K., Swain, S., Hasnain, M.S.; Development and validation of RP-HPLC method for quantitation of amoxicillin trihydrate in bulk and pharmaceutical formulations using Box-Behnken experimental design, Journal of Liquid Chromatography & Related Technologies, 2012; 35:393-406. https://doi.org/10.1080/10826076.2011.601493
8. Ashnagar, A., Naseri, N.G.; Analysis of three penicillin antibiotics (ampicillin, amoxicillin and cloxacillin) of several Iranian pharmaceutical companies by HPLC, E-Journal of Chemistry, (2007); 4:536-545. https://doi.org/10.1155/2007/480907
9. Samanidou, V.F., Evaggelopoulou, E.N., Papadoyannis, I.N.; Development of a validated HPLC method for the determination of four penicillin antibiotics in pharmaceuticals and human biological fluids, Journal of Separation Science, 2006; 29:1550-1560. https://doi.org/10.1002/jssc.200600081
10. Foulstone, M., Reading, C.; Assay of amoxicillin and clavulanic acid, the components of Augmentin, in biological fluids with high-performance liquid chromatography, Antimicrobial Agents Chemotherapy, 1982; 22:753-762. https://doi.org/10.1128/AAC.22.5.753
11. Kasnia V, Kumar MS, Mahadevan N, Int J. Simultaneous estimation of amoxicillin, tinidazole and omeprazole in microsphere formulation by RP-HPLC, recent Adv Pharm Res. J Acta Pharm 2012; 2(2):78-83.
12. Chaudhary A, Dhaiya M, Tyagi S, Mittal S, Method Development and Validation of Polmacoxib in Capsule Dosage Form by RP-HPLC, Journal of Drug Delivery and Therapeutics. 2021; 11(4-S):59-63. https://doi.org/10.22270/jddt.v11i4-S.4984
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