Validation and Application of a New Reversed Phase HPLC Method forIn VitroDissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets

Abstract

The purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify in vitro dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form. Method development was performed on C 18, 100 × 4.6 mm ID, and 10 μm particle size column, and injection volume was 20 μL using a diode array detector (DAD) to monitor the detection at 280 nm. The mobile phase consisted of buffer: acetonitrile at a ratio of 60 : 40 (v/v), and the flow rate was maintained at 1.0 mL/min. The method was validated in terms of suitability, linearity, specificity, accuracy, precision, stability, and sensitivity. Linearity was observed over the range of concentration 0.05–12.0 μg/mL, and the correlation coefficient was found excellent >0.999. The method was specific with respect to rabeprazole sodium, and the peak purity was found 99.99%. The method was precise and had relative standard deviations (RSD) less than 2%. Accuracy was found in the range of 99.9 to 101.9%. The method was robust in different variable conditions and reproducible. This proposed fast, reliable, cost-effective method can be used as quality control tool for the estimation of rabeprazole sodium in routine dissolution test analysis.

Development and validation of dissolution testings in acidic media for rabeprazole sodium delayed-release capsules

“…Drug solubility and solution stability are important properties to be considered when selecting the dissolution medium 32 . It is still important for good water solubility drugs to keep the stability in physiology dissolution media with pH range from 1.0 to 6.8, although some research 3 , 32 have reported that high pH media such as pH 7.5 PBS, pH 8.0 Tris buffer, and pH 9.0 borate buffer were used for dissolution testing to assess the enteric properties of RAB-coated tablets. High pH dissolution media can be used for quality control of oral solid dosage form of RAB, but little in vitro–in vivo correlation can be afforded from the aspect of Biopharmaceutics Classification System (BCS).…”

“…It is widely used in the treatment of active peptic ulcers, severe gastro-oesophageal reflux disease (GERD) and Zollinger-Ellison syndrome through suppressing the gastric acid secretion 2–4 . Because it rapidly degrades in acid media and is more stable under alkaline conditions 3 , RAB is usually prepared into enteric-coated dosage forms such as pellets, capsules, and tablets.…”

“…Many analytical methods reported in the literatures were used to determined preparations of RAB like spectrophotometry 8–13 and spectroflourimetric methods 14 , 15 , electrochemical methods 16 , 17 and chromatography such as high-performance liquid chromatography (HPLC) methods 18–22 , thin layer chromatography (TLC) method 23 , and high-performance thin layer chromatography (HPTC) methods 11 , 24 . A number of works describing the determination of rabeprazole in biological fluids 25–31 and dissolution testing for enteric-coated tablets 3 , 4 , 32 were also reported in the literatures. However, it is difficult to use these analytical methods, especially common HPLC, to directly determine the accumulative release amount of RAB in acidic media due to its degradation in the course of dissolution.…”

Inhibition of Gastric H⁺,K⁺-ATPase Activity <i>in Vitro</i> by Dissolution Media of Original Brand-Name and Generic Tablets of Lansoprazole, a Proton Pump Inhibitor

“…1,2) It is widely used for the treatment of active peptic ulcers, severe gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome by suppressing gastric acid secretion. [2][3][4] From a pharmaceutical point of view, lansoprazole is assigned to class II drugs having low solubility and high permeability according to the biopharmaceutical classification system; it is a weak base (pK a =8.87) and poorly soluble in water (3.2×10 −2 mg/mL at pH 7.0 and 25°C). Furthermore, lansoprazole is an acid-labile drug by nature 3) ; thus, an enteric coating (pH-dependent coating) is essential for the oral dosage form.…”