Estimation Of Esomeprazole Research Articles

Development and Validation of Stability Indicating Method for Simultaneous Estimation of Esomeprazole and Levosulpiride by HPTLC using Experimental Design

The present study examines simultaneous multiple response optimization using desirability function for the development of an HPTLC method to detect esomeprazole magnesium trihydrate and levosulpiride in pharmaceutical dosage form. HPTLC separation was performed on aluminium plates pre-coated with silica gel 60 F254 as the stationary phase using ethyl acetate:methanol:toluene:ammonia (7:1.5:1.5:0.1% v/v/v) as the mobile phase. Full factorial design applied for the optimization of degradation condition. Esomeprazole magnesium trihydrate and levosulpiride were subjected to acid, alkali hydrolysis, oxidation and photodegradation. Experimental full factorial design has been used during forced degradation to determine significant factors responsible for degradation and to optimize degradation conditions reaching maximum degradation. 32 and 23 full factorial design has been used for optimization of chromatographic condition in acid and base degradation study, respectively. Quantification was achieved based on a densitometric analysis of esomeprazole magnesium trihydrate and levosulpiride over the concentration range of 800-4000 ng/band and 1500-7500 ng/band, respectively at 254 nm. The method yielded compact and well-resolved bands at Rf of 0.70 ± 0.02 and 0.32 ± 0.02 for esomeprazole magnesium trihydrate and levosulpiride, respectively. The linear regression analysis for the calibration plots produced r2 = 0.9967 and r2 = 0.9981 for esomeprazole magnesium trihydrate and levosulpiride, respectively. Method is validated as per ICH (Q2)R1 guideline.

Quality by Design (QBD) Approach to Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Esomeprazole and Naproxen in Tablet Dosage Form

Quality by Design (QBD) Approach to Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Esomeprazole and Naproxen in Tablet Dosage Form

Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Esomeprazole and Domperidone in Tablet Formulation

A new simple, rapid, precise, and specific assay method was developed for simultaneous estimation of Esomeprazole and Domperidone in pure form and tablet form. The analysts were separated by RP HPLC on a RP-Purosnosphere C18 column (5 μm, 4.6mm, 250 mm). The mobile phase was methanol: water (72: 28 v/v) at 1.0 mL/min satisfactorily resolved the binary mixture. The UV detector was operated at 289 nm for the determination of both the drugs. Linearity, accuracy and precision were found to be acceptable over the concentration ranges of 20–120 μg/ml for Esomeprazole and Domperidone with a R2 0.9998 and 0.9990 values respectively, in binary mixture. The optimized method proved to be specific, robust and accurate for the quality control in bulk drug and pharmaceutical formulations.

Complexity in Estimation of Esomeprazole and its Related Impurities' Stability in Various Stress Conditions in Low-Dose Aspirin and Esomeprazole Magnesium Capsules

A complex, sensitive, and precise high-performance liquid chromatographic method for the profiling of impurities of esomeprazole in low-dose aspirin and esomeprazole capsules has been developed, validated, and used for the determination of impurities in pharmaceutical products. Esomeprazole and its related impurities’ development in the presence of aspirin was traditionally difficult due to aspirin’s sensitivity to basic conditions and esomeprazole’s sensitivity to acidic conditions. When aspirin is under basic, humid, and extreme temperature conditions, it produces salicylic acid and acetic acid moieties. These two byproducts create an acidic environment for the esomeprazole. Due to the volatility and migration phenomenon of the produced acetic acid and salicylic acid from aspirin in the capsule dosage form, esomeprazole’s purity, stability, and quantification are affected. The objective of the present research work was to develop a gradient reversed-phase liquid chromatographic method to separate all the degradation products and process-related impurities from the main peak. The impurities were well-separated on a RP8 column (150 mm × 4.6mm, X-terra, RP8, 3.5μm) by the gradient program using a glycine buffer (0.08 M, pH adjusted to 9.0 with 50% NaOH), acetonitrile, and methanol at a flow rate of 1.0 mL min−1 with detection wavelength at 305 nm and column temperature at 30°C. The developed method was found to be specific, precise, linear, accurate, rugged, and robust. LOQ values for all of the known impurities were below reporting thresholds. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal degradation in the presence of aspirin. The developed RP-HPLC method was validated according to the present ICH guidelines for specificity, linearity, accuracy, precision, limit of detection, limit of quantification, ruggedness, and robustness.

Simultaneous Estimation of Esomeprazole and Domperidone in Combined Dosage form by HPLC

A simple, accurate, reliable and reproducible HPLC method was developed for the simultaneous determination of esomeprazole and domperidone in combined dosage forms. The method employed C18 phenomenex column, acetate buffer: acetonitrile: methanol (55:35:10) as mobile phase and detection was made at 290nm. The retention times were found to be 6.76 and 4.42 min for ESO and DOMPE respectively. The method was validated as per ICH guidelines. The method shows good linearity, accuracy, and precision, limit of detection and limit of quanti- fication. The linearity range was found between 4-19 µg/mL for both ESO and DOMPE with relative standard deviation of 0.022 and 0.076 respectively. The value for LOD was found to be 0.3 µg/mL and 0.4 µg/mL and LOQ was found to be 1.5 µg/mL and 2.5 µg/mL for ESO and DOMPE respectively. The main recovery was found to be 99.81 ± 1.27 and 100.43 ± 1.15 for ESO and DOMPE respectively. The method was suitable for routine analysis of ESO and DOMPE both individually and in combined dosage forms.

Simultaneous estimation of esomeprazole and domperidone by UV spectrophotometric method

A novel, simple, sensitive and rapid spectrophotometric method has been developed for simultaneous estimation of esomeprazole and domperidone. The method involved solving simultaneous equations based on measurement of absorbance at two wavelengths, 301 nm and 284 nm, λ max of esomeprazole and domperidone respectively. Beer's law was obeyed in the concentration range of 5-20 μg/ml and 8-30 μg/ml for esomeprazole and domperidone respectively. The method was found to be precise, accurate, and specific. The proposed method was successfully applied to estimation of esomeprazole and domperidone in combined solid dosage form.