DEVELOPMENT AND VALIDATION ANALYSIS OF ACYCLOVIR TABLET CONTENT DETERMINATION METHOD USING FTIR
Objective: The aim of this research is to develop the fourier transforms infrared spectroscopy (FTIR) as an alternative method for determination acyclovir content in the tablet dosage form.
Methods: Infra-red spectrum of acyclovir were transformed to be its first derivative, then measured the AUC (area under the curve). Calibration curve was made in a series of the concentration of 0.2-1.2% w/w, and some wavenumbers spectra's area were choiced. Some validation parameters: specificity, linearity, limit of detection, limit of quantification, accuracy and precision were evaluated, then this validated method was used to determine the content of acyclovir in three tablet dosage forms found from the market.
Results: The optimal wavenumber obtained was shown at 3700-3440 cm-1, next it was used during validation test, which produced the excellent yields of all validation parameters. Furthermore, this method was used for tablets content determination.
Conclusion: All the results from this research showed that FTIR can be used as a validated alternative method, more rapid and simple for determine the content of acyclovir in a tablet.
2. Basavaiah K, Prameela HC, Chandrashekar U. Simple high-performance liquid chromatographic method for the determination of acyclovir in pharmaceuticals. Il Farmaco 2003;58:1301-6.
3. Basavaiah K, Prameela HC. Quantitative methods for the assay of acyclovir in the nonaqueous medium. Indian J Chem Technol 2004;11:759-63.
4. Patil PM, Wankhede SB, Chaudhari PD. A validated stability indicating HPTLC method for estimation of acyclovir in tablets in the presence of its alkaline hydrolysis degradation product. Bull Fac Pharm Cairo Univ 2014;52:245-57.
5. United States Pharmacopeia Convention. The United States Pharmacopeia. 30th ed. The National Formulary. 25th rev. Rockville: United States Pharmacopeia Convention Inc; 2007. p. 680.
6. Health Department of Indonesia. Indonesian Pharmacopoeia. 5th ed. Jakarta: Health Department of Indonesia; 2014. p. 57.
7. Stuart B. Infrared Spectroscopy: Fundamentals and applications. Sydney: John Wiley and Sons Inc; 2004. p. 53.
8. Bhongade B, Talath S, Dhaneshwar S. A validated method dor the quantitation of ciprofloxacin hydrochloride using diffuse reflectance infrared fourier transform spectroscopy. Int J Spectrosc 2014:1-6. Doi.org/10.1155/2014/294612. [Article in Press]
9. Karpinska J. Basic principles and analytical application of derivative spectrophotometry, Macro to Nano Spectroscopy. Poland: Bialystok; 2012. p. 254-68.
10. Nugrahani I, Ibrahim S, Mauludin R, dan Krisnamurthi P. Study of hydrate transformation of sefradoxil monohydrate dan sefalecsin monohydrate using FTIR. J Mol Sci 2012;18:1-10.
11. Matkovic SR, Valle GM, Briand LE. Quantitative analysis of ibuprofen in pharmaceutical formulations through FTIR spectroscopy. Latin Am Appl Res 2005;35:189-95.
12. Mallah MA, Sherazi STH, Mahesar SA, Rauf A. Assesment of azithromycin in pharmaceutical formulation by fourier transform infra-red (FTIR) transmission spectroscopy. Pak J Anal Environ Chem 2011;12:61-7.
13. Rohman A, Musfiroh A, Wijaya EG. Quantitative determination of simethicone in antacid suspension and chewable tablet using FTIR spectroscopy. Global J Pharmacol 2013;7:270-5.
14. Tavarez GD, Ishikawa SM, Maonteiro TF, Zanolini C, Kedorhackmann EM, Consilieri NA. a Derivative spectrophotometric method for determination of acyclovir in polymeric nanoparticles. Quim Nova 2012;35:203-6.
15. Harmita. Guideline of validation and its calculation method. MIK 2004;1:113-35.
16. Mills III T, Roberson JC, Christian CM, Simon MJ, Burns MD, dan Ollis RJ Jr. Instrumental data for drug analysis. Boca Raton: CRC Press: Taylor and Francis Group; 2006. p. 3, 48.