Development and Validation of RP-HPLC Method for Simultaneous Estimation of Aspirin and Esomeprazole Magnesium in Tablet Dosage Form

Dipali Patel,Nishitkumar Patel,Chiragsinh Solanki,Viral Patel,Reeta Vaishy,Mitul Patel

doi:10.1155/2013/751940

Dipali Patel, Nishitkumar Patel + Show 4 more

Open Access

https://doi.org/10.1155/2013/751940

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Abstract

A simple, specific, precise, and accurate reversed-phase HPLC method was developed and validated for simultaneous estimation of aspirin and esomeprazole magnesium in tablet dosage forms. The separation was achieved by HyperChrom ODS-BP C18column (200 mm × 4.6 mm; 5.0 μm) using acetonitrile: methanol: 0.05 M phosphate buffer at pH 3 adjusted with orthophosphoric acid (25 : 25 : 50, v/v) as eluent, at a flow rate of 1 mL/min. Detection was carried out at wavelength 230 nm. The retention times of aspirin and esomeprazole magnesium were 4.29 min and 6.09 min, respectively. The linearity was established over the concentration ranges of 10–70 μg/mL and 10–30 μg/mL with correlation coefficients (r2) 0.9986 and 0.9973 for aspirin and esomeprazole magnesium, respectively. The mean recoveries were found to be in the ranges of 99.80–100.57% and 99.70–100.83% for aspirin and esomeprazole magnesium, respectively. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of aspirin and esomeprazole magnesium in their combined tablet dosage form.

Highlights

Aspirin (ASP) is chemically 2-(acetyloxy)-benzoic acid (Figure 1)
Accuracy was determined by calculating the recovery. e method was found to be accurate with % recovery 99.80–100.57% for ASP and 99.70–100.83% for Esomeprazole magnesium (ESO) respectively
Precision was calculated as repeatability and intra and interday variation for both the drugs. e method was precise with % RSD 0.14–0.38 for intraday and % RSD 0.38–0.83 for interday for ASP and 0.22–0.49 for intraday and % RSD 0.22–0.86 for interday for ESO, respectively

Summary

Introduction

Aspirin (ASP) is chemically 2-(acetyloxy)-benzoic acid (Figure 1) It is nonselective cyclooxygenase inhibitor used as an antipyretic, analgesic, anti-in ammatory, and antithrombotic agent. Esomeprazole magnesium (ESO) is S-isomer of omeprazole and proton pump inhibitor It is magnesium, bis [5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2pyridinyl)methyl]sul nyl]-1H-benzimidazolato] (Figure 2). E review of literature revealed that various analytical methods involving spectrophotometry [4,5,6], HPLC [7,8,9,10] and HPTLC [11] have been reported for ASP in single form and in combination with other drugs. Several analytical methods have been reported for ESO in single form and in combination with other drugs including spectrophotometry [12, 13], HPLC [14, 15], and HPTLC [16]. E present work describes the development of a simple, precise, accurate, and reproducible HPLC method for the simultaneous estimation of ASP and ESO in combined dosage form. e developed method was validated in accordance with ICH Guidelines [17] and successfully employed for the assay of ASP and ESO combine dosage form

Experimental Condition

Determination of ESO and ASP from Combined Dosage Form

Results and Discussion

Conclusion