DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRICMETHOD FOR QUANTITATIVE ESTIMATION OF GLIPIZIDEIN PHARMACEUTICAL DOSAGE FORM
Keywords:Glipizide, UV-Spectrophotometric method, Method Development and validation, Dimethyl Form amide
Objective: The present work is aimed to develop a simple, rapid, selective and economical UV spectrophotometric method for quantitative determination of Glipizideinbulk and pharmaceutical dosage form.
Methods: In this method Dimethyl Form amide (DMF) was used as solvent, the absorption maxima was found to be275 nm in DMF. The developed method was validated for linearity, accuracy, precision, ruggedness, robustness, LOD and LOQ in accordance with the requirements of ICH guideline.
Results: The linearity was found to be 10-60 µg/ml having linear equation y=0.017x-0.006 with correlation coefficient of 0.997. The% recovery was found to be in the range of 98.7-100%. The % RSD for intra-day and inter-day precision was found to be 0.569923 and 0.40169 respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be3.06 µg/ml and 9.27 µg/ml respectively.
Conclusion: The developed method was validated as per ICH Q2(R1) guidelines. The novel method is applicable for the analysis of bulk drug in its pharmaceutical dosage form.
2. Karkhanis VV. Development and validation of UV spectrophotometric method for estimation of glipizide in bulk and pharmaceutical dosage forms. Int J Pharm Sci Res 2013;4:1865-7.
3. Chungath TT. Simultaneous spectrophotometric estimation of metformin hydrochloride and glipizide tablet. Int J PharmTech Res 2011;3:2064-7.
4. Rathod DR, Dole MN. Spectrophotometric determination of glipizide in bulk and tablet dosage form by absorption maxima, first order derivative spectroscopy and area under curve. Asian J Pharma Clin Res 2012;5:102-4.
5. Basavaiah KK, Rajendraprasad NH. Stability-indicating Uv-spectrophotometric determination of glipizide in pharmaceuticals. Austin J Anal Pharma Chem 2017;4:1-7.
6. Nipanikar MS, Baokar SS. Ultraviolet spectrophotometric method for determination of glipizide in bulk and tablet dosage formulation. Res J Pharm Dosage Form Tech 2016;11:234-9.
7. Patil GS. Development and validation of UV spectrophotometric method for simultaneous estimation of metformin and glipizide tablet formulation. Int J Appl Pharm Sci Res 2016;1:56-9.
8. Buddhadev SV, Kashyap RS. Development and validation of simultaneous equation method for bilayer floating tablet of glipizide and lisinopril. Int J Innovative Pharm Sci Res 2015:3:212-20.
9. Jena BR, Swain SS. UV spectrophotometric method developmentand quantitative estimation of glipizide in bulkand pharmaceutical dosage forms. Int J Drug Res Tech 2017;7:112-22.
10. Sarangi RR, Panda SN. Simultaneous UV-spectrophotometric estimation of glipizide and metformin in bulk and its dosage form. Int J Pharm Biol Arch 2011;2:1137-45.
11. https://www.drugbank.ca/drugs/DB01067. [Last accessed on 10 Oct 2019].
12. ICH Guidelines Q2 (R1). Validation of analytical procedures: text and methodology. In: ICH Harmonized Tripartite Guidelines; 2005.