Abstract
BackgroundThe present work describes the development and validation of a new, specific, accurate, and precise stability-indicating RP-HPLC method for the simultaneous estimation of Esomeprazole (ESP) and Naproxen (NAP) in modified-release bi-layer tablet dosage form. Analytical Quality by Design concept was implemented through the method development exercise to establish the robustness of the method.ResultsMethod development was performed on C18, 250 × 4.6 mm ID, and 5 µm particle size column with 10 µl injection volume using a photodiode array (PDA) detector to monitor the detection at 280 nm. The mobile phase consisted of the buffer: methanol at a ratio of 50: 50 (v/v), and the flow rate was maintained at 1.5 ml/min, and the column oven temperature was maintained at 30 °C. The retention times for NAP and ESP were found 5.9 ± 0.1 and 8.9 ± 0.1 min, respectively. The method was validated in terms of system suitability, specificity, accuracy, linearity, precision, and solution stability. Linearity was observed over the range of concentration 8–12 µg/ml for ESP and 200–300 µg/ml for NAP, and the correlation coefficient (R2) was found excellent > 0.999. The method was specific to ESP and NAP, and the peak purity was found 99.97% for ESP and 100.00% for NAP. The method was precise and had %RSD less than 2. Recovery study for accuracy with placebo was found in the range of 99.63–100.36% for ESP and 99.91–100.43% for NAP.ConclusionThis proposed fast, reliable, cost-effective method can be used as a quality control tool for the simultaneous determination of Esomeprazole and Naproxen in routine laboratory analysis.Graphical
Highlights
The present work describes the development and validation of a new, specific, accurate, and precise stability-indicating reversed-phase high-performance liquid chromatography (RP-High-Performance Liquid Chromatography (HPLC)) method for the simultaneous estimation of Esomeprazole (ESP) and Naproxen (NAP) in modified-release bi-layer tablet dosage form
Method optimization After selecting the proper diluents or solvents, preliminary trials were carried out with a mobile phase consisting of phosphate buffer and MeOH or ACN
The flow rate of 0.5–1.5 ml/min was studied with a different combination of pH mobile phases to obtain an optimum retention time not compromising on the resolution
Summary
The present work describes the development and validation of a new, specific, accurate, and precise stability-indicating RP-HPLC method for the simultaneous estimation of Esomeprazole (ESP) and Naproxen (NAP) in modified-release bi-layer tablet dosage form. Quality by Design (QbD) is a modern approach to quality. Product and manufacturing process quality are the goals of pharmaceutical development [1, 2]. Poor manufacturing standards and their quality is being a worry for the industries and the regulatory agencies despite the continuous contribution by the pharmaceutical industries in new drug discovery and innovations [3]. Juran, who is the world’s wellknown expert in quality control, has extended the philosophies of quality from the ancient conventional statistical practice to modern quality management [4]. Juran is the man behind the quality of Japanese, suggests the need for managerial processes that focus on quality. The three managerial processes explained by Juran comprises of quality planning, quality control, and quality improvement, these three processes are combined called Juran’s Trilogy [5]. Juran invented the term "quality by design" in his well-known publication "Juran on Quality by Design." Juran believed that quality could be strategic and that most quality problems were related to the way quality was strategized [6, 7]
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