QUANTITATIVE ASSAY OF ASPIRIN AND (SALICYLIC ACID AND HEAVY METALS AS IMPURATIES) IN IRAQI’S MARKET ASPIRIN TABLETS USING DIFFERENT ANALYTICAL METHODS
DOI:
https://doi.org/10.22159/ijap.2018v10i5.26820Keywords:
HPLC, Salicylic acid, Heavy metals, Aspirin tabletsAbstract
Objective: Easy and precise methods were developed for estimation of aspirin (ASP), impurities from such as salicylic acid (SAL) and heavy metal ions (HMI) in ASP tablets that available in the Iraqi’s market using High-performance liquid chromatography (HPLC), UV–VIS spectrophotometry and atomic absorption spectrophotometric (AAS).
Methods: HPLC separation was carried out using C18 as stationary phase and acetonitrile (ACN): water in the ratio of (10: 90 v/v) as a mobile phase for HPLC method and as a solvent for UV-VIS spectrophotometric for quantitative ASP and SAL at 254 nm for HPLC, 226 and 296 nm for UV measurements. AAS was used for HMI determination.
Results: ASP and SAL gave absorbance maxima at 226 and 296 nm in ACN: H2O solvent. The Beer’s law was obeyed in the range of 0.05-20 for ASP and 0.02-8 µg/ml for SAL. Correlation coefficients (R2) were 0.9996 and 0.9992 for ASP and SAL respectively, for HPLC and LOD value was 0.006 for ASP and 0.004 μg/ml for SAL. The % recovery for the developed method was found to be in the range of (98.80 to 101.26%) and (98.67 to 103.33%) for ASP and SAL respectively, within the acceptable range, that approved by world health organization (WHO).
Conclusion: The proposed method can help research studies, quality control and routine analysis with lesser resources available. The results of the assay of pharmaceutical formulation of the developed method are highly reliable and reproducible and is in good agreement with the label claim of the medicines.
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References
Muchtaridi M, Yuliani E, Sopyan I. Application off-line SPE-HPLC/UV methods in the analysis in human (in vitro). Int J Pharm Pharm Sci 2015;8:255–61.
Khan HN, Bandewar SS, Zameeruddin M, Bharkad VB. Development and validation of RP-HPLC method for simultaneous determination of aspirin and omeprazole. Der Pharm Chem 2017;9:55-8.
Kumar SS, Jamadar DL, Bhat K, Prashant B, Musmade B, Vasantharaju SG, et al. Analytical method development and validation for aspirin. Int J ChemTech Res 2010;2:389-99.
Pawar PY, Ankita R, Lokhande BR, Bankar AA. Simultaneous estimation of atorvastatin calcium and aspirin in pure and capsule dosage form by using UV spectrophotometric method. Der Pharm Chem 2013;5:98-103.
Bae SK, Seo KA, Jung EJ, Kim HS, Yeo CW, Shon JH, et al. Determination of acetylsalicylic acid and its major metabolite, salicylic acid, in human plasma using liquid chromatography–tandem mass spectrometry: application to pharmacokinetic study of astrix® in Korean healthy volunteers. Biomed Chromatogr 2008;22:590-5.
US Food and Drug Administration. Guidance for Industry, Q3A Impurities in New Drug Substances; 2003.
US Food and Drug Administration. Guidance for Industry, Q3B Impurities in New Drug Products; 2006.
Desai NC, Senta RD. Simultaneous RP-HPLC determination of salicylamide, salicylicacid and deferasirox in the bulk API dosage forms. JTUSCI 2015;9:245–51.
Acheampong A, Addai-Arhin S, Apau J, Gyasi WO. Development and validation of a RP-HPLC method with PDA detection for the simultaneous estimation of acetylsalicylic acid, paracetamol and caffeine in fixed dose combination tablets. Int J Chem Biomol Sci 2015;1:211-7.
Patila AS, Khairnara BJ, Maneb DV, Chaudharia BR. A validated stability-indicating HPLC related substances method for salicylic acid in bulk drug and dosage form. World J Pharm Sci 2015;3:1184-90.
Gousuddin MD, Sengupta P, Tripathi VD, Das A. Stability indicating RP-HPLC method for simultaneous determination of aspirin and clopidogrel in dosage form. MJAS 2016;20:247-57.
Hullah Bhuyian MD, Rashid DH, Islam AF, Tareque MD. Development and validation of method for determination of clobetasol propionate and salicylic acid from pharmaceutical dosage form by HPLC. BJPR 2015;7:375-85.
Skoog DA, Holler FJ, Crouch SR. Instrumental analysis. 11thed. Delhi: Cengage Learning India Pvt Ltd; 2012.
Huber L. Validation of analytical methods and processes. In: The Pharmaceutical codex, principles and practice of pharmaceutics. 12th ed. London: The Pharmaceutical Press; 1994. p. 507-24.
Davidson AG. Ultraviolet-visible absorption spectro-photometry. In: Beckett AH, Stenlake JB. editors. Practical pharmaceutical chemistry. 4thed. Part 2. New Delhi: CBS Publishers and distributors; 2002. p. 275-337.
Ahmed MS, Noor QA. Simultaneous spectrophotometric determination of aspirin and codeine. Res J Pharm Biol Chem Sci 2017;8:1137-43.
Salako Q, Fadiran EO, Thomas WO. Detection and determination of salicylic acid impurity in aspirin tablet formulation by HPLC. Afr J Med Med Sci 1989;18:215-8.
Somaya ST, Khairi SA, Abdussalam SA, Mohammad MK. Atomic absorption analysis of toxic heavy metal impurities in various commercial aspirin formulations. AB 2015;3:9-14.