Sanapala Srinivasa Rao, A. Vijayalakshmi
Sanapala Srinivasa Rao*, A. Vijayalakshmi
School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai-117, Tamil Nadu, India.
Volume - 14,
Issue - 3,
Year - 2021
A simple, precise, accurate method was developed for the estimation of Glipizide by RP-UPLC technique. Chromatographic conditions used are stationary phase BEH C18 (100mm x 2.1mm,1.8µm). Mobile phase composition of 0.01N KH2PO4: acetonitrile in the ratio of 50:50 and flow rate was maintained at 0.3ml/min, detection wave length was 234nm, column temperature was set to 30oC. System suitability parameters were studied by injecting standard six times and results were well under the acceptance criteria. Linearity study was carried out for 25% to 150% levels and R2 value was found to be 0.999. Precision was found to be 0.5 for repeatability and 0.3 for intermediate precision. LOD and LOQ are 0.05µg/ml and 0.14µg/ml respectively. By using above method, assay of marketed formulation was found to be 100.03%. Degradation studies of Glipizide were done in all conditions. Purity threshold was more than purity angle and lies within the acceptable range.
Cite this article:
Sanapala Srinivasa Rao, A. Vijayalakshmi. Analytical Method Development and Validation of Glipizide by RP-UPLC Method. Research J. Pharm. and Tech 2021; 14(3):1370-1374. doi: 10.5958/0974-360X.2021.00244.4
1. British Pharmacopoeia, the Stationary Office, London, 2005.
2. Validation of analytical procedures Text and methodology, Q2 (R1). International Conference on Harmonization, Harmonized Tripartite Guideline 2005, 1-13.
4. Indian Pharmacopoeia, Ministry of Health and Family Welfare, Government of India, New Delhi, 1996.
5. Neraj Kumar Saini, Suresh P. Sulochana, Mohd Zainuddin, Ramesh Mullangi. Development and validation of a novel method for simultaneous quantification of enzalutamide, darolutamide and their active metabolites in mice dried blood spots using LCMS/MS: application to pharmacokinetic study in mice. ADMET and DMPK 2018; 6(3): 242-257.
6. Sulochana SP1, Saini NK1, Daram P1, Polina SB2, Mullangi R3. Validation of an LC-MS/MS method for simultaneous quantitation of enzalutamide, N-des methyl enzalutamide, Glipizide, darolutamide and ORM-15341 in mice plasma and its application to a mice pharmacokinetic study. 2018; 15; 156: 170-180.
9. Rakshit Kanubhai Trivedi, Mukesh Patel Development and validation of a stability indicating RP-UPLC method for determination of quetiapin in pharmaceutical dosage form, Scientia Pharmacutica 2011: 79: 97-111.
10. Rakshit Kanubhai Trivedi, Mukesh Patel C and Amit Kharkar. Determination of mesalamine related impurities from drug product by reversed phase validated UPLC method. E-Journal Chemistry. 2011, 8(1), 131-148.
11. Cristiana C. Leandro, Peter Hancock, Richard J. Fussell, Brendan J. Keely: Comparison of ultra-performance liquid chromatography and high-performance liquid chromatography for the determination of priority pesticides in baby foods by tandem quadrupole mass spectrometry. Journal Chromatography - A. 2006, 1103 (1), 94-101.
12. Hua Jin, Avvaru Praveen Kumar, Do-Hyeon Paik, Kwon-Chul Ha, Young-Jae Yoo, Yong-Ill Lee. Trace analysis of tetracycline antibiotics in human urine using UPLC–QTOF mass spectrometry. Microchem Journal, 2010, 94(2), 139-147.