Review Article

Validation of HPLC-UV method for determination of amoxicillin Trihydrate in capsule

Sendanyoye Marcel*, Uwambajineza Tito, Ineza Ines and Nahimana Jean Pierre

Published: 04 October, 2018 | Volume 2 - Issue 1 | Pages: 055-072

The intention of the present work is to validate an easy, better and reasonable approach for estimation of amoxicillin trihydrate in tablet formulation by opposite segment(reverse phase) HPLC –UV with advanced conditions and parameters for habitual use in Rwanda well known board in pharmaceutical laboratory in order to check if no substandard or counterfeit amoxicillin has entered in our country that can result in antimicrobial resistance, treatment failure which can be a chief difficulty on public health. an easy, selective, precise, speedy, specific, and correct reverse phase HPLC UV-seen technique has been verified for the dedication of amoxicillin, in addition that is a cost-effective technique for the established method, monobasic potassium phosphate (KH2PO4) used as buffer and methanol and had been used as a mobile section in the ratio 95:5 respectively. The elution turned into finished in an isocratic mode at a go with the flow rate of 1.5ml/minute proposed method became demonstrated as according to ICH guiding principle refereeing additionally to USP necessities for amoxicillin capsule. linearity range of amoxicillin and was evaluated inside the variety of 20–160 g/ml. the correlation coefficient r2 changed into 0.9998 and the relative well known deviation between six replicates injection was always much less than 2%. The retention time was found 3.5±0.02. the high percentage of healing of amoxicillin is 100.6±4% indicates that the proposed method is exceptionally correct and precise trueness of with the trueness of 100.06±1.2% .the statistical evaluation proved that the demonstrated method is appropriate for analysis of amoxicillin as the majority drug and pharmaceutical formula with none interference from excipients .with the aid of considering the efficiency of the drug samples, all analyzed pattern were within the variety of 90-120 % of percentage of labeled amount, but the efficiency had been distinctive amongst samples. The have a look at located that no counterfeit, no substandard product turned into amongst all batches of amoxicillin samples throughout the c programming language of the look at.

Read Full Article HTML DOI: 10.29328/journal.aac.1001014 Cite this Article Read Full Article PDF


Reverse phase; HPLC –UV; Counterfeit; Antimicrobial resistance; Buffer; Potency


  1. : https://goo.gl/qcv41u
  2. Indian pharmacopoeia. Ghaziabad, The Indian pharmacopoeia commission. 2003; 3: 2090-2095. Ref.: https://goo.gl/mKvK6a
  3. British pharmacopoeia, her majesty’s stationary office. London. 2003; 3: 719-721.
  4. http://msds.chem.ox.ac.uk/am Ref.: https://goo.gl/JPbfNA
  5. The american society of health-system pharmacists. retrieved 1 august 2015. Ref.:
  6. Basic principles of hplc ppt by martin r. hackman nj- depoffice of quality assurance Ref.: https://goo.gl/5NaEfz
  7. Koerner PJ. General principles of hplc method development, Thailand 2013: Ref.: https://goo.gl/huK1Ye
  8. : https://goo.gl/8LzS2M
  9. Chapter 18, “Quality assurance for drug procurement,” of managing drug supply 2nd ed. Management sciences for health and world health organization. 1997;
  10. The International Pharmacopoeia. 2003; 5: Ref.: https://goo.gl/6dmv18
  11. : https://goo.gl/YC1Hdq
  12. Schulze M. Transfer of validated methods into laboratories working routine.
  13. Thompson M, Stephen l, Ellison R, wood R. Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report). in: pure appl chem. 2009; 74: 835–855, Ref.: https://goo.gl/eSn6L6
  14. Guidance for Industry. Ind meetings for human drugs and biologics, chemistry manufacturing and controls 529 information. 2001; Ref.: https://goo.gl/enMeZw
  15. Inds for phase 2 and 3 studies of drugs, including specified therapeutic biotechnology- 532 derived products. 1999;
  16. Investigating out of specification (oos) test results for pharmaceutical production. 2006; Ref.: https://goo.gl/gQt3ck
  17. Guidance for Industry. Process validation: general principles and practices. 18. u.s. 2011; Ref.: https://goo.gl/xkXUQ3
  18. Department of health and human services, food and drug administration center for drug evaluation and research (cder), center for biologics evaluation and research (cber) (july 2015 pharmaceutical quality/cmc)” analytical procedures and methods validation for drugs and biologics (guidance for industry)”
  19. Guidance for industry: international conference on harmonization)
  20. q1c stability testing for new dosage forms. 1997; Ref.: https://goo.gl/QBWFZP
  21. q2(r1) validation of analytical procedures: text and methodology. 1995;1997; Ref.: https://goo.gl/weJhxX
  22. Pharmacopoeia (usp 37). Validation of compedial methods.
  23. Prazuck T, Falconi I, Morineau G, Bricard-Pacaud V, Lecomte A, et al. Quality control of antibiotics before the implementation of an std program in northern myanmar. Sex Transm Dis. 2002; 29: 624-627 Ref.: https://goo.gl/tXbrzz
  24. Shabir GA. Step-by-step analytical methods validation and protocol in the quality system compliance industry. Ref.: https://goo.gl/xrc8kH
  25. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, validation of analytical procedures: text and methodology q2(r1), current step 4 version parent guideline dated 27 october 1994 (complementary guideline on methodology dated 6 november 1996 incorporated in november 2005).
  26. The international conference on harmonization, q2(r1), validation of analytical procedure, text and methodology. 2005; 1-13.
  27. Ahmed M, Suresh Babu G, Shetty SK. Development and validation of amoxicillin by rp-hplc method in bulk drug and pharmaceutical dosage forms, international journal of chemtech research coden(usa). 2011; 3: 1037-1041. Ref.: https://goo.gl/nPEQtX
  28. Claver KP. Quantitative drug analysis and evaluation of the influence of accelerated stability testing on the in vitro dissolution.
  29. Webster K. Statistical analysis in analytical method validation. 2013; : https://goo.gl/KGNMGm


Figure 1

Figure 1

Figure 1

Figure 2

Similar Articles

Recently Viewed

Read More

Most Viewed

Read More

Help ?