Kalleshvar P. Jatte, R. D. Chakole, M. S. Charde
Mr. Kalleshvar P. Jatte*, R. D. Chakole, M. S. Charde
Post Graduate Department of Pharmaceutical Chemistry, Government College of Pharmacy, Vidyanagar, Karad, Dist.: Satara, Pin- 415124, Maharashtra, India.
Volume - 11,
Issue - 4,
Year - 2021
RP-HPLC method was developed for the estimation of Lisinopril and Hydrochlorothiazide in tablet dosage form with the help of Quality by Design (QbD) approaches. In this method concentration of each drug was obtained by using the absorptivity values calculated for drug wavelength 226.0 nm and solving the equation. The RP-HPLC method was performed C18-(100mm x 4.6 mm,)2.5 µm particle size in gradient mode, and the sample was analysed using methanol 45.0 ml and 55.0 ml (pH 3.3 0.05% OPA with TEA) as a mobile phase at a flow rate of 0.8 ml/min and detection at nm. By the retention time for Lisinopril and Hydrochlorothiazide found 3.39 and 4.59 min respectively. Validation related the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots by both HPLC were linear over the 5-25 and 12.5-62.5 µg/ml for Lisinopril and Hydrochlorothiazide respectively, and recoveries from tablet dosage form were between 99.02 and 100.00 %. The method can be used for routine of the quality control in pharmaceuticals. The degradation profiling of Lisinopril and Hydrochlorothiazide were also carried out.
Cite this article:
Kalleshvar P. Jatte, R. D. Chakole, M. S. Charde. Degradation Profiling of Lisinopril and Hydrochlorothiazide by RP- HPLC method with QbD Approach. Asian Journal of Pharmaceutical Analysis. 2021; 11(4):270-4. doi: 10.52711/2231-5675.2021.00046
Kalleshvar P. Jatte, R. D. Chakole, M. S. Charde. Degradation Profiling of Lisinopril and Hydrochlorothiazide by RP- HPLC method with QbD Approach. Asian Journal of Pharmaceutical Analysis. 2021; 11(4):270-4. doi: 10.52711/2231-5675.2021.00046 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-4-4
1. Anjaneyules Y., Chandrasekhar K.A text book of Analytical Chemistry, 1st ed. Publisher ministry of defence, defence research and development organization, recruitment and organization centre, Lukhnow Road, Timarpur Delhi, 2006: p.1.
2. Rashmin. An introduction to analytical method development for pharmaceutical formulations. Pharma info.net, 2008: 6(4): p.1.
3. Sethi. PD. In; HPTLC Quantitative analysis of pharmaceutical formulations, 1st ed. CBS publishers and distributors, New Delhi, 2001; preface IIV, p.3.
4. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental Methods of Analysis. A 7th ed. CBS Publisher and Distributors, New Delhi.p.5.
5. Sethi PD. High Performance Liquid Chromatography Quantitative Analysis of Pharmaceutical Formulation. Ist ed. New Delhi: CBC Publication and Distributors; 2001.p.35.
6. Sethi PD. High Performance Liquid Chromatography. Quantitative Analysis of Pharmaceutical Formulations. Ist ed. New Delhi CBS Publication and Distributors, 2001. p.116-120.
7. Cindy Green, RAC. A Step By Step Approach to Establishing a Method Validation. Journal of Validation Technology August 2007; 13(4): p.317-323.
8. Skoog D, Holler F, Nieman T. Principles of Instrumental Analysis. 5th ed. New Delhi: Thomson Books; 2006.p.11-16.
11. Qbd approach to analytical RPHPLC. Devesh A. Bhatt, Smita I. Rane. Dhule : International Journal of Pharmacy and Pharmaceutical Sciences, 2011, vol. 3. Issn 0975-1491
14. Medical Subject Headings (MeSH).
15. Hazardous Substances Data Bank (HSDB).
16. Y.Anjaneyalu, K.Chandrasekar, Valli Manickam. Text book of Analytical Chemistry. S.L. : Pharma Book Syndicate.
17. Gurdeep R. Chatwal, Sham K. Anand. Instrumental Methods of Chemical Analysis. New Dehli : New Delhi: Himalaya Publishing House, 2008. 5.