Development, validation and stability study of UV spectrophotometric method for determination of Repaglinide in bulk and pharmaceutical dosage forms
Abstract
A Simple, fast and reliable spectroscopic method has been developed for development, validation and stability study of Repaglinide in the pharmaceutical dosage forms. The quantitative determination of the drug was carried out by using of double beam UV-Visible spectrophotometer at wavelength 237nm. Calibration graph constructed at wavelength 237nm was linear in concentration range of 10μg/ml to 90μg/ml with correlation co-efficient 0.999. This method was validated as per ICH guidelines and can be used for determination Repaglinide in the pharmaceutical dosage forms.
Keywords:
Repaglinide, UV-Visible double beam spectrophotometer, Validation
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References
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3. Yoshioka, Sumie and Stella, Valentino J.: Stability of Drugs and Dosage Forms. Springer, New Delhi, 1st ed, C2000:4-37.
4. Lachman, Leon, Lieberman, Herbert A., Kanig, Joseph L.: The Theory and Practice of Industrial Pharmacy, Varghese, Bombay, 3rd ed, 1987:760-803.
5. Connors, Kenneth A., Amidon, Gordon L., Stella, Valentino J.: Chemical Stability of Pharmaceuticals: A Handbook for Pharmacist. John Willey & Sons, New York, 2nd ed, C1986:82-105.
6. Tonnesen, H. Hjorth: The Photostability of Drugs and Drug Formulations. Taylor & Francis, London, 1st ed, C1996:305-321.
7. Sethi, P. D.: High Performance Liquid Chromatography: Quantitative Analysis of Pharmaceutical Formulations.., CBS, New Delhi, 1st ed, 2001:116-136.
8. Ahuja, Satinder, Rasmussen, Henrik: HPLC Method Development for Pharmaceuticals. Elsevier London, C2007:13-43.
9. Lindsey, Sandie: High Performance Liquid Chromatography: Analytical Chemistry by Open Learning. John Willey, New York, 2nd ed C1987, 17-36.
10. ICH, Q2A (R1) Validation of analytical procedure, International Conference on Harmonization, 1995.
11. ICH, Q1A (R2) Stability testing of new drug substances and products, International Conference on Harmonization, 2003.
12. ICH, Q2B Validation of analytical procedure: methodology, International Conference on Harmonization, 1997.
13. Radjenovic. J, Perez. S, Petrovic. M and Barcelo. D. Identification and Structural Characterization of Biodegradation Products of Atenolol and Glibenclamide by Liquid Chromatography Coupled to Hybrid Quadrupole Time-of-Flight and Quadrupole Ion Trap Mass Spectrometry. Journal of Chromatography A 2008; 1210(2):142-153.
14. Bae Jung-Woo, Tae Kim Nam, Choi Chang-Ik, Kim Mi-Jeong, Jang Choon-Gon and Lee Seok-Yong. HPLC Analysis of Plasma Glipizide and Its Application to Pharmacokinetic Study. Journal of Liquid Chromatography & Related Technologies 2009; 32(13):1969 – 1977.
15. Seedher Neelam and Kanojia Mamta. Co-Solvent Solubilization of Some Poorly-Soluble Antidiabetic Drugs. Pharmaceutical Development and Technology 2009; 14(2):185–192.
16. Ruzilawati Abu Bakar, Mohd Suhaimi Abd. Wahab, Ahmad Imran, Zabidah Ismail and Siew Hua Gan. Method Development and Validation of Repaglinide In Human Plasma by Hplc and Its Application In Pharmacokinetic Studies. Journal of Pharmaceutical and Biomedical Analysis 2007; 43(5):1831-1835.
17. Jing Yao, Ya-Qin Shi, Zhuo-Rong Li and Shao-Hong Jin. Development of A RP-HPLC Method For Screening Potentially Counterfeit Anti-Diabetic Drugs. Journal of Chromatography B 2007; 853(1-2):254-259.
18. Ming Wang and Miksa Irina R. Multi-Component Plasma Quantitation of Anti-Hyperglycemic Pharmaceutical Compounds Using Liquid Chromatography–Tandem Mass Spectrometry. Journal of Chromatography B 2007; 856(1-2):318-327.
19. Mistri Hiren N, Jangid Arvind. G and Shrivastav. S Pranav. Liquid Chromatography Tandem Mass Spectrometry Method for Simultaneous Determination of Antidiabetic Drugs Metformin and Glyburide in Human Plasma. Journal of Pharmaceutical and Biomedical Analysis 2007; 45(1):97-106.
20. Florin Albu, Cristina Georgiţa, Victor David and Medvedovici Andrei. Determination of Glibenclamide In Human Plasma by Liquid Chromatography and Atmospheric Pressure Chemical Ionization/Ms-Ms Detection. Journal of Chromatography B 2007; 846(1-2):222-229.
Published
30/09/2016
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J, M., K, N. S., & K, S. S. (2016). Development, validation and stability study of UV spectrophotometric method for determination of Repaglinide in bulk and pharmaceutical dosage forms. Journal of Innovations in Applied Pharmaceutical Science (JIAPS), 1(3), 10-16. Retrieved from https://saap.org.in/journals/index.php/jiaps/article/view/176
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