DEVELOPMENT AND VALIDATION OF ESOMEPRAZOLE RESIDUE IN DOMESTIC WATER BY USING REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (10) ◽  
pp. 63-66
Author(s):  
Lakshmi Tulasi S. ◽  
Swamy V. V. S. A. ◽  

As more concern arises day by day for the environmental pollution due to pharmaceutical products and their toxic nature, analytical methods require characterizing drug substances and drug product composition during all phases of environmental habitats, mainly in water habitats. A simple, sensitive, and accurate analysis has been developed to estimate esomeprazole in pharmaceutical effluents, which are released from the pharmaceutical industries into the aquatic environment, by using RP-HPLC with UV detection. The developed method is highly reproducible and sensitive to determine the esomeprazole at less than 10 ppm 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 the C18 Gemini NX column (150 mm × 4.6 mm id., 5.0 μm). 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 a retention time of about 5.0 min. The method was validated for accuracy, precision, specificity, linearity and sensitivity.

Author(s):  
SRUTHI A ◽  
UTTAM PRASAD PANIGRAHY

Objective: A rapid, sensitive and specific reverse phase High performance liquid Chromatography (RP-HPLC) method was developed for the estimation of Fimasartan in bulk and pharmaceutical dosage form. Method: The RP-HPLC analysis was performed isocratically on a Primacel C18 column (150 mm × 4.6 mm internal diameter, 5 μm particle size) using mobile phase of composition Acetonitrile and 0.1% orthophosphoric Acid in 80:20, v/v proportions with a flow rate of 0.8 ml/min. Results: The analyte was monitered with UV-detector at 265 nm. In the developed method Fimasartan elutes at a typical retention time of 2.4 min. The proposed method is having linearity in the concentration ranging from 5-30 μg/ml of Fimasartan. Conclusion: : The method was statistically validated and had been applied to analysis of the drug in bulk and pharmaceutical dosage form.


Author(s):  
Susithra E ◽  
Pavani Ch

Objective: The immense literature study was carried out and disclosed that here no method arrived for the concomitant assessment of omeprazole and piperine in bulk form by using RP-HPLC. Hence, an effort was assembled to arise a easy, specific, precise, reliable, linear, rapid, and validated reverse phase-high-performance liquid chromatography (RP-HPLC) technique for the simultaneous assessment of omeprazole and piperine in bulk form.Methods: The chromatographic analysis of omeprazole and piperine was performed using a RP-HPLC (WATERS) provided with autosampler and ultraviolet (UV) detector with the software of EMPOWER Version 2. The chosen conditions were isocratic separation with two mobile phase composed of acetonitrile:buffer (phosphate buffer: pH 6.5 ± 0.1) (55:45). Detection was carried out using UV/visible double-beam spectrophotometer at 320 nm. The method was validated as per the ICH guidelines.Results: The retention time for omeprazole and piperine by proposed HPLC method was found to be 2.767 and 4.029 min, respectively. The correlation coefficients are 0.999. The developed chromatographic method was found to be accurate with recovery 99.2–99.8% and was found within the acceptance criteria (i.e., 98.0–102.0%) with acceptable % relative standard deviation of not >2% at each level.Conclusion: Thus, the proposed HPLC procedure for the concomitant assessment of omeprazole and piperine was accurate, precise, linear, robust, simple, and economic. 


Author(s):  
Vaishali Mistry ◽  
Akshay Yelwe ◽  
Amey Deshpande

Objective: The present study describes the stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of 5-fluorouracil and tegafur in pharmaceutical dosage forms.Method: 5-fluorouracil and tegafur the propose RP-HPLC method were developed by using Shimadzu Prominence-i LC-2030 HPLC system equipped with UV detector and chromatographic separation was carried on shim-pack gist c18 (250 × 4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 10 min. The mobile phase consisted of methanol and water in the ratio of 50:50% v/v and elements were scanned using a UV detector at 271 nm.Result: The retention time of 5-fluorouracil and tegafur was found to be 2.74 and 3.66 min, respectively. A linearity response was observed in the concentration range of 13.4 μg/ml–31.3 μg/ml for 5-fluorouracil and 6 μg/ml–14 μg/ml for tegafur, respectively. Limit of detection and limit of quantification of 5-fluorouracil were 10.97 μg/ml and 33.26 μg/ml and for tegafur are 4.89 μg/ml and 14.83 μg/ml, respectively.Conclusion: The stability indicating that the method was developed by subjecting drugs to stress conditions such as acid and base hydrolysis, oxidation, photo and thermal degradation, and degraded products formed were resolved successfully from samples.


Author(s):  
Padmaja V ◽  
Prasanthi M ◽  
Mayuri P

Objectives: The purpose of the research is to develop a simple, precise, economical, accurate, reproducible, and sensitive method for the estimation of methylcobalamin, alpha-lipoic acid, pyridoxine hydrochloride, and folic acid drug product by reversed-phase high-performance liquid chromatography (RP-HPLC) method.Methods: New analytical method was developed for the estimation of methylcobalamin, alpha-lipoic acid, pyridoxine hydrochloride, and folic acid in drug product by RP-HPLC. The chromatographic separation was achieved on the Inertsil C18, 250 mm × 4.6 mm, 5 μm at ambient temperature. The separation achieved employing a mobile phase consists of buffer (added 5.05 g hexane-1-sulfonic acid is dissolved into 1000 mL of distilled water):acetonitrile in the ratio of 10:90% v/v. The flow rate was 1 mL/min and UV-visible spectrophotometer at 285 nm. The average retention time for methylcobalamin, alpha-lipoic acid, pyridoxine hydrochloride, and folic acid was found to be 3.5, 6.7, 8.5, and 9.3, respectively.Results: The developed method was validated as per ICH guidelines. All validation parameters were within the acceptable ranges. The assay methods were found to be linear from 0 to 2130 μg/mL for methylcobalamin, 0 to 142.5 μg/mL for alpha-lipoic acid, 0–4.54 μg/mL for pyridoxine hydrochloride, and 0–2 μg/mL for folic acid. The correlation coefficient was 0.999 for all drugs, respectively. The mean percentage values for the developed method were found to be within the range of 98–100.6%. The developed method was also found to be robust.Conclusion: It is concluded that developed method was accurate, precise, linear, reproducible, robust, and sensitive.


Author(s):  
Nutan Rao ◽  
Kajal D Gawde

Objective: The present study describes the stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of salbutamol sulfate (SAL), etofylline (ETO), and bromhexine hydrochloride (BROM) in pharmaceutical dosage forms.Methods: The proposed RP-HPLC method was developed using Shimadzu prominence-i LC-2030 HPLC system equipped with ultraviolet (UV) detector and chromatographic separation was achieved isocratically using Shim-pack C18 (250 mm×4.6mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 13 min. The mobile phase consisted of acetonitrile: 0.1M potassium dihydrogen phosphate buffer (35:65) with pH adjusted to 3.0 and eluents were scanned using UV detector at 225 nm.Result: The retention time of SAL, ETO, and BROM was found to be 2.319 min, 2.698 min, and 10.329 min, respectively. The calibration curve was linear over the concentration ranges of 1.6–3.2 μg/ml, 160–320 μg/ml, and 6.4–12.8 μg/ml for SAL, ETO, and BROM, respectively.Conclusion: The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, humidity, and photo- and thermal degradation and the degraded products formed were resolved successfully from the samples. Therefore, the proposed method can be used as a more convenient and efficient option for the simultaneous estimation of all the three drugs in bulk and combined


Author(s):  
Javed S Shaik ◽  
Nutan N Rao

Objective: The present study describes the stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of amiloride hydrochloride and furosemide in pharmaceutical dosage forms.Methods: The proposed RP-HPLC method was developed using Shimadzu LC-2030 HPLC system equipped with UV detector, and chromatographic separation was carried on Shim-pack C18 (250 mm×4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the runtime was 4min. The mobile phase consisted of water and acetonitrile in the ratio of 35:65, and elements were scanned using a UV detector at 281 nm.Results: The retention time of amiloride hydrochloride and furosemide was found to be 1.92 min and 3.14min, respectively. Linearity was found to be 12–28 ppm for amiloride hydrochloride and 96–224 ppm for furosemide, respectively. Limit of detection and limit of quantification for amiloride hydrochloride were 0.381 ppm and 1.156 ppm and for furosemide were 2.00 ppm and 6.068 ppm, respectively.Conclusion: The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, humidity, photolytic, and thermal degradation, and the degraded products formed were resolved successfully from the samples.


2014 ◽  
Vol 4 ◽  
pp. 40
Author(s):  
Safila Naveed ◽  

A simple, rapid, isocratic, high-performance liquid chromatography (RP-HPLC) method has been developed for the first time for simultaneous determination of ACE inhibitors (captopril, lisinopril and enalapril) and diclofenac sodium in bulk drugs, pharmaceutical products and human serum.


Author(s):  
Raju Chandra ◽  
Manisha Pant ◽  
Harchan Singh ◽  
Deepak Kumar ◽  
Ashwani Sanghi

A reliable and reproducible reversed-phase high performance liquid chromatography (RP-HPLC) was developed for the quantitative determination of Remipril drug content from marketed bulk tablets. The active ingredient of Remipril separation achieved with C18 column using the methanol water mobile phase in the ratio of 40:60 (v/v). The active ingredient of the drug content quantify with UV detector at 215 nm. The retention time of Remipril is 5.63 min. A good linearity relation (R2=0.999) was obtained between drug concentration and average peak areas. The limit of detection and limit of quantification of the instrument were calculated 0.03 and 0.09 µg/mL, respectively. The accuracy of the method validation was determined 102.72% by recoveries method.


1985 ◽  
Vol 65 (2) ◽  
pp. 285-298 ◽  
Author(s):  
J. E. KRUGER ◽  
B. A. MARCHYLO

Chromatographic conditions were optimized and three commercially available columns were evaluated for separation of alcohol-soluble storage proteins of Neepawa wheat using reversed-phase high-performance liquid chromatography (RP-HPLC). Optimal separation was achieved using an extracting solution of 50% 1-propanol, 1% acetic acid, and 4% dithiothreitol and an HPLC elution time of 105 min at a flow rate of 1.0 mL/min. HPLC columns evaluated (SynChropak RP-P, Ultrapore RPSC and Aquapore RP-300) varied in selectivity and resolution. The column providing the greatest versatility was Aquapore RP-300 available in cartridge form. Sodium dodecyl sulfate gradient-gel electrophoresis analysis of protein peaks resolved by RP-HPLC indicated that many of the eluted peaks contained more than one protein species. Chromatographic protein patterns obtained for Neepawa wheat grown at different locations and in different years were qualitatively the same.Key words: Protein, high-performance liquid chromatography, wheat


2010 ◽  
Vol 2 (7) ◽  
pp. 142-147
Author(s):  
O. Amos Abolaji ◽  
M. Ubana Eteng ◽  
E. Patrick Ebong ◽  
Andi Brisibe ◽  
Ahmed Shakil ◽  
...  

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