STABILITY INDICATING METHOD DEVELOPMENTAND VALIDATION FOR PANTOPRAZOLE USING RP-HPLC

Abstract

AIM: To develop and validate simple, accurate, sensitive, rapid and economical methods for simultaneous
estimation of the drug from tablet dosage forms using RP-HPLC method
MATERIALS & METHODS: pH meter Eutech, Weighing balance Denver, Ultrasonicator UCA 701
Unichrome, HPLC LC Waters 2695- Empower software, Flow rate 1mL/min, Pump Isocratic model
REAGENTS AND CHEMICALS: Water HPLC, Acetonitrile HPLC, Formic acid HPLC, Tri fluoro acetic
acid hplc, Pantoprazole was purchased from Indian market manufactured by USV, (Mumbai). Commercial
pharmaceutical preparation of Pantoprazole tablets contain 100 mg was used in analysis
RESULTS: wavelength was selected at which the drugs showed maximum absorbance. The wavelength
selected was 290 nm. X-Bridge phenyl (250mmx 4.6mm, 5µ). 0.1% formic acid: ACN (50:50v/v)used as mobile
phase Retention time of Pantoprazole was about 3.746 The % assay should be within range of 98-102%,
Linearity range 10-200 µg/ml Correlation coefficient0.999, LOD = 0.125 LOQ = 0.412,Method Precision
0.612. Assay 100.1
CONCLUSION: Hence, the developed chromatographic method for Pantoprazole is said to be rapid, simple,
precise, accurate, specific and cost effective that can be effectively applied for the routine analysis