DEVELOPMENT AND VALIDATION OF REVERSE PHASE-HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY TECHNIQUE FOR THE CONCOMITANT ASSESSMENT OF OMEPRAZOLE AND PIPERINE IN BULK FORM
DOI:
https://doi.org/10.22159/ajpcr.2018.v11s4.31718Keywords:
Omeprazole, Piperine, Reverse phase-high-performance liquid chromatography, Validation, Simultaneous evalutionAbstract
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.
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References
Available from: http://www.drugbank.ca/drugs/DB00338.
Available from: http://www.rxlist.com/prilosec-drug.htm.
Available from: http://www.medicine.nevada.edu/wps/Proceedings/52/18-20_PWPS-52-0111.pdf.
Available from: http://www.questhealthlibrary.com/herbs/piperine.
Available from: http://www.drmajeed.com/articles/2000TheMedicinalUsesOfPepper.pdf.
Snyder LR, Kirkland JJ, Glajch JI. Practical HPLC Method Development. 2nd ed. New York: Wiley; 1997.
ICH QIA (R2). Stability Testing of New Drug Substances and Products; 2003.
ICH, Q2B. Validation of Analytical Procedure: Methodology. Geneva: International Conference on Harmonization, IFPMA; 2005.
ICH. Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology; 1996.
Validation of Analytical Procedure: Methodology, ICH Harmonized Tripartite Guidelines; 1996.
Skoog A, West M. Principles of Instrumental Analysis. 2nd ed. Washington, DC: Saunders College Pub; 1998. p. 666-709.
Beckett AH, Stenlake JB. Practical Pharmaceutical Chemistry. 4th ed., Vol. 2. New Delhi: CBS Publishers and Distributors; 1997. p. 157-74.
Connors KA. A Textbook of Pharmaceutical Analysis. 3rd ed. New Delhi: Wiley Inter Sciences Inc.; 1994. p. 373-421.
Skoog, DA, West DM, Holler FJ, Crouch SR. Fundamentals of Analytical Chemistry. 8th ed. Belmont, CA: Thomson-Brooks/Cole; 2004. p. 644-55.
Douglas A, Holler SF, Nieman TA. Principles of Instrumental Analysis. Singapore City: Thomson Asia Pte Ltd.; 2005. p. 725-60.
Watson DG. Pharmaceutical Analysis. In: A Text Book for Pharmacy Students and Pharmaceutical Chemists. 2nd ed. Harcourt Publishers Limited.; 2005. p. 221-32, 311.
Willard HH, Merrit LL, Dean JA, Settle FA. Instrumental Methods of Analysis. 6th ed. New Delhi: CBS Publishers and Distributors; 1986. p. 1-15.
Sharma BK. Instrumental Methods of Chemical Analysis. 19th ed. Meerut: Goel Publishing House; 2000.
Sethi PD. High-Performance Liquid Chromatography. 1st ed. New Delhi: CBS Publisher; 2001. p. 1-103.
Vogel AI, Bassett J. Vogel’s Text Book of Quantitative Inorganic Analysis. London, New York: Longman; 1962. p. 193-208.
Ewing GW. Instrumental Methods of Chemical Analysis. New York: McGraw Hill Book Co., Inc.; 1985. p. 340-5.
Sethi PD. Quantitative Analysis of Drugs in Pharmaceutical Formulations. 3rd ed. New Delhi: CBS Publisher; 1997. p. 51-64.
Chatwal GR, Anand SK. Instrumental Methods of Chemical Analysis. Girgaon,Mumbai: Himalaya Publishing House Pvt. Ltd.; 2007. p. 2566-638.
Snyder LR, Kirkland JJ, Joseph LG. Practical HPLC Method Development. 2nd ed. New York: Wiley Inter Science; 1997. p. 1-56, 234- 89, 685-712.
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