DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF ESOMEPRAZOLE SODIUM BY HPLC
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2016, Vol 7, Issue 5
Abstract
A very simple, accurate, specific, precise and rapid reverse phase high performance liquid chromatography technique has been built up as well as validated to determine the Esomeprazole Sodium. The method is applicable for the quantitative analysis of the drug substance. Chromatographic separation was achieved on a Supelco 250-mm, 4.6-mm, and 5-μm C-18 analytical column with a mixture of Buffer and Acetonitrile at a volume ratio of 55:45 (v/v) as mobile phase at a flow rate of 1.0 mL /min. The molecule eluted within a short runtime (within 7.0 min). The eluted compound was monitored at a detector wavelength of 302 nm and the column oven temperature was maintained at 25 °C. The developed method was validated according to ICH guidelines. The high recovery and low relative standard deviation confirm the suitability of the method for determination of Esomeprazole Sodium. The repeatability and intermediate precision, expressed by the % RSD, were less than 2%. Accuracy (% recovery: 98.00-102.00%) was found to satisfactory. The method was validated by determining its accuracy, precision, system suitability, linearity and robustness. Validation studies reveal that the method is simple, specific, rapid, reproducible, precise and accurate, which is useful for the routine determination of Esomeprazole Sodium.
Authors and Affiliations
Farhana Lipi , Md. Islam , Shahida Parvin
Keywords
Related Articles
- EP ID EP106981
- DOI 10.7897/2230-8407.07543
- Views 138
- Downloads 0
ANTIPYRETIC POTENTIAL OF GALEGA PURPUREA ROOT
The methanolic extract of the roots of Galega purpurea (MEGP) was investigated for its antipyretic activity in rats. Hyperpyrexia was induced by subcutaneous administration of Brewer’s yeast suspension. The extracts were...
ANTINOCICEPTIVE ACTIVITY OF COLD WATER EXTRACT OF DESMODIUM TRIFLORUM IN RATS
The aim of this study was to examine antinociceptive potential of cold water extract (CWE) of Desmodium triflorum (Family: Fabaceae / Leguminosae) plant. One of four doses of CWE (dose 4000 mg/ml, 2000 mg/ml and 1000 mg...
DESIGN AND CHARACTERIZATION OF CLARITHROMYCIN BEADS USING A BIODEGRADABLE CATIONIC POLYMER
The objective of the present study was to prepare clarithromycin beads by ionotropic gelation method using cationic polymer. Infra red spectroscopy study showed that the drug and excipients were compatible with each othe...
COMPARATIVE CLINICAL STUDY OF JATYADI VARTI AND ARAGWADADI VARTI IN THE MANAGEMENT OF NADI VRANA (PILONIDAL SINUS)
Nadi vrana (Pilonidal sinus), a type of Dushta vrana, commonly seen in Sacro-coccygeal region, is a condition wherein a blind tract is formed, with its opening in the skin or near the cleft at the top of the buttocks and...
EVALUATION OF ANALGESIC POTENTIAL OF KIGELIA PINNATA LEAF EXTRACT IN WISTAR RATS
The main aim of the present study is to evaluate the analgesic activity of leaf extract of Kigelia pinnata on wistar rats. Analgesic activity of the leaf extract of Kigelia pinnata at a dose of 200 mg/kg & 400 mg/kg...