Articles Accepted

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHODS BY RP-HPLC FOR THE ESTIMATION OF PHARMAEUTICAL RESIDUAL CONTENT IN DOMESTIC WATER RESOURCES
by Mrs. s.lakshmi tulasi, 17 Oct 2019

As the more concern was arising day by day for the environmental pollution due to pharmaceutical products and their toxic nature, Analytical methods require characterizing drug substances and drug products composition during all phases of environmental habitats mainly in water habitats. A number of drugs are being introduced in the market every year, and these are either new drugs or the modification of the existing moieties. Because of the possible uncertainties in the continuous use of these drugs, appearance of some new toxicities and patient resistance or introduction of some better drugs leads to a time lag from the date of introduction of these drugs in the market to the date of its inclusion in pharmacopoeias. So there is a need to develop and validate newer analytical techniques for such drugs as it may not be available in pharmacopoeias A simple, sensitive and accurate analytical has been developed to estimate esomeprazole in pharmaceutical effluents, which are releasing from the pharmaceutical industries into aquatic environment by using RP-HPLC with UV detection. the developed method is highly reproducible and sensitive to determine the esomeprazole in less than 10ppm level.A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of Esomeprazole in effluents or pharmaceutical industry washouts. The separation was achieved on C18 Gemini NX column (150mm × 4.6mm i.d., 5.0μm) using a mixed buffer of sodium dihydrogen phosphate monohydrate and dibasic sodium phosphate anhydrous having a pH of 7.3 as buffer, and the mobile phase is a mixture of 350mL buffer: 500mL acetonitrile:150mL of water in isocratic mode as mobile phase and at a flow rate of 0.8 mL/min. Detection was carried out using a UV detector at 302 nm. The total chromatographic analysis time per sample was about 10.0 min with Esomeprazole eluting at retention time of about 5.0 min. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. Validation studies demonstrated that this HPLC method is accurate, specific, rapid, reliable, and reproducible. Linearity was observed for Esomeprazole in the concentration range of 0.025–10 µg/mL (R2 > 0.95), The limit of detection (LOD) and limit of quantitation (LOQ) was found to be 0.003µg/ml and 0.009 µg/ml respectively for Esomeprazole, the method was validated as per ICH guidelines. The RSD for intra-day and inter-day precision were found to be less than 5%. The percentage recovery was in good agreement and the method is simple, specific, precise, and accurate for the determination of Esomeprazole in the pharmaceutical industry washouts.

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