Gopikrishna YENDURI, Srinivasu NAVULURI

Analytical high performance liquid chromatography method for estimating the combination of aspirin and omeprazole in bulk and tablet dosage form

A HPLC method was developed for the estimation of aspirin and omeprazole simultaneously in bulk drug and tablet dosage forms. 0.1 M potassium dihydrogen phosphate and acetonitrile in the ratio of 55:45 v/v at pH of 4.5 was used successfully as the mobile phase for the analysis of the selected drugs. Analysis of the selected drugs was carried out using Zodiac C18 (150 × 3.0 mm, 5 µm) column. The calibration range for omeprazole was 0.08-24 µg/ml, whereas, for aspirin was 0.65-195 µg/ml. The LOD and LOQ values were; 0.199 μg/ml and 0.65 μg/ml for aspirin, 0.024 μg/ml and 0.080 μg/ml for omeprazole, respectively. The percentage recovery of aspirin and omeprazole was found to be 99.75%-99.92% and 99.46%-99.57%, respectively. Percentage relative standard deviation (RSD%) was found to be in the range of 0.083%-0.085% for aspirin and 0.045%-0.047% for omeprazole. Forced degradation studies (such as alkaline, acidic, oxidative, thermal and photolytic degradation conditions) were performed on tablet sample as per the ICH guidelines. The peaks of degradants are well separated from the main peaks of aspirin and omeprazole. The proposed HPLC method was successfully applied for the quantification of aspirin and omeprazole in its pharmaceutical dosage forms without interference from common excipients.

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[1] Valentin F, Joseph MS. Aspirin: A historical and contemporary therapeutic overview. Circulation. 2011; 123 (7): 768- 778.

[2] Vane JR, Botting RM. The mechanism of action of aspirin. Thromb Res. 2003; 110 (5-6): 255-258.

[3] Dick S, Sushama K, Joseph Mc, Rajah K. Pharmacology of nonsteroidal antiinflammatory drugs and opioids. Semin Intervent Radiol. 2010; 27 (4): 400-411.

[4] Rod F. What are all the things that aspirin does?. BMJ. 2003; 327 (7415): 572-573.

[5] Paez Espinosa EV, Murad JP, Khasawneh FT. Aspirin: Pharmacology and clinical applications. Thrombosis. 2012; 2012: Article ID 173124.

[6] Dean L. Omeprazole Therapy and CYP2C19 Genotype. 2012 Oct 1 [Updated 2016 Mar 8]. In: Medical Genetics Summaries [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2012.

[7] Raymond SY Tang, Justin CY Wu. Managing peptic ulcer and gastroesophageal reflux disease in elderly Chinese patients – focus on esomeprazole. Clin Interv Aging. 2013; 8: 1433-1443.

[8] Raul B, Dawn F. Diagnosis and treatment of gastroesophageal reflux disease. World J Gastrointest Pharmacol Ther. 2014; 5 (3): 105-112.

[9] Alice M, Giuseppina O. Delayed-release oral suspension of omeprazole for the treatment of erosive esophagitis and gastroesophageal reflux disease in pediatric patients: a review. Clin Exp Gastroenterol. 2010; 3: 17-25.

[10] Maliheh S, Reyhaneh S, Alireza F. Treatment of Helicobacter pylori infection: Current and future insights. World J Clin Cases. 2016; 4 (1): 5-19.

[11] http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100165/yosprala-aspirin-andomeprazole

[12] Tushar S, Kevin B, Rahul C, Udaya T, Paul AG. Efficacy of aspirin (325 mg) + omeprazole (40 mg) in treating coronary artery disease. Expert Opin Pharmacother. 2017; 18 (1): 123-131.

[13] Patta S, Afreen S, Tappa S, Nagarajan G, GnanaPrakash K, Simultaneous estimation of aspirin and omeprazole (YOSPRALA) in bulk by UV-spectroscopy. J Drug Deliv Ther. 2017; 7(3): 87-91.

[14] International Conference on Harmonization Q1A, Stability Testing of New Drug Substances and Products, ICH Secretariat, Geneva, 1993.

[15] International Conference on Harmonization Q1B, Stability testing: Photostability Testing of New Drug Substances and Products, Proceeding of the International Conference on Harmonization, Geneva, 1996.

[16] International Conference on Harmonization, ICH Guidelines, Validation of analytical procedures technical requirements for registration of pharmaceuticals for human use: Text and Methodology Q 2 (R1), International Conference on Harmonization, Geneva, Switzerland, November 2005.