Abstract

FORMATION AND VALIDATION OF AN ANALYTICAL METHOD FOR THE SIMULTANEOUS ASSESSMENT OF ASPIRIN AND OMEPRAZOLE IN TABLET DOSAGE FORM BY RP-HPLC

Atif Ali*, Asia Kiran, Zahid Mehboob, Dr. Syed Alam Zeb, Sadaf Ismat, Sayed Muzahir Hussain, Zulfiqar Ahmad and Muhammad Mudassar Ali

ABSTRACT

YOSPRALA is a newly developed tablet that, due to its immediate release of Omeprazole (40 mg) and delayed release of Aspirin (81 mg) or (325 mg) dose power, is effective for cardiovascular as well as gastrointestinal safety. Yosprala was approved for cardiovascular and cerebrovascular diseases by the USFDA in Sept 2016. Aspirin is an antiplatelet agent & Omeprazole is an inhibitor of the proton pump. Purpose: To develop a modern, reliable, clear, fast, inexpensive and sensitive RP-HPLC method to quantify aspirin and Omeprazole tablet form. Method: On RP-HPLC, the separation of these molecules is accomplished by using the column of PHENOMENEX C8 (150 × 4.6mm, 5μm). This accomplishment is accomplished with the help of a mobile phase containing a 75:25 ratio of phosphate buffer (ph 7.5) and acetonitrile, with a sample induction of 20μl. At 280 nm, the wavelength is chosen with a flow rate of 01 ml/min. Results: The retention time of Aspirin was found to be 2.2 and for Omeprazole it was 8.4min. The linearity range is 32-48μg/ml and 8-12μg/ml for Aspirin and omeprazole respectively. The correlation coefficient was 0.9996 forAspirin and omeprazole. The procedure was validated for accuracy and less than 2.0 percent RSD was found for both aspirin and omeprazole. For standard deviation, relative standard deviation, coefficient of variance and the results were within the range, the methodology was statistically validated. The above method is therefore simple, affordable, cost-effective, economical and durable.

Keywords: Yosprala; Aspirin; Omeprazole; HPLC.