Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Development and Validation of Rp-hplc Method for the Estimation of Alogliptin in Api and Tablet Formulation


Affiliations
1 D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India
     

   Subscribe/Renew Journal


The analytical method was developed and validated for determination of Alogliptin in bulk and pharmaceutical dosage forms by High performance liquid chromatography. The separation was carried out on Zorbax SB-Aq (250 x4.6mm,5μ ID) column. The mobile phase consists of 0.1% TFA Water : ACN in the ratio 62:38 at flow rate 1ml/min with diode array detector wavelength at 290nm.The column temperature was adjusted at 30º ± 0.5°C with injection volume 10μl.The retention time of Alogliptin was 3.06min. The linearity of the calibration curve was linear over the concentration range 25-75μg/ml (r2=1). The validation was carried out as per ICH guidelines. The development of method was easy, rapid, linear, precise, accurate and consistent.

Keywords

Alogliptin, RP-HPLC, Validation, Method development, 290nm and diode array detector.
Subscription Login to verify subscription
User
Notifications
Font Size


  • G. Srinivasa Rao, K. Mallesh, G. Vijay Kumar, Ch. Surekha and B, Venugopala Rao, A Validated Chiral HPLC Method for the Enantiomeric Purity of Alogliptin Benzoate, Der Pharma Chemica, 6(3), 234-239 (2014). https://www.derpharmachemica.com/abstract/a-validated-chiral-hplc-method-for-the-enantiomeric-purity-of-alogliptin-benzoate-1909.html

  • International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text on Validation of Analytical Procedures Q2A, 1994. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf

  • R. I. El-Bagary, E. F. Elkady and B. M. Ayoub, Liquid Chromatographic Determination of Alogliptin in Bulk and in its Pharmaceutical Preparation, Int. J. Biomed. Sci., 8(3), 1-5 (2012). https://eurekamag.com/research/054/140/054140476.php

  • International Conference on Harmonization (ICH), Validation of Analytical Procedures: Methodology Q2B, 1996. https://www.ikev.org/haber/stabilite/kitap/36%201.8%20%20Stability%20Workshop%20ICH%20Q2B%20C%20.pdf

  • P. J. Yadav, S. Jadhav amd K. Mohite, Development and Validation of RP-HPLC Method for Alogliptin Benzoate in Bulk Drug and Dosage Form, IJPPR. Human, 1(2), 1-9(2014). https://www.ijppr.humanjournals.com/wp,content/uploads/2014/08/Yadav_Priyanka_J.__Jadhav_Sayali_S.__Mohite_S._K..pdf

  • International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology Q2 (R1), 2005. https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf

  • Usami Yoshiko, Tsuyoshi Oki, Naka Masahiko, Sagisaka Masafumi, Kaneda Tsuguhiro. A simple HPLC method for simultaneous determination of Lopinavir, Ritonavir and Efavirenz. Journal-Chemical and pharmaceutical bulletin 2003; 51:715-718. https://pubmed.ncbi.nlm.nih.gov/12808252/

  • Mabrouk M. M., Hammad S. F., Mansour F. R., Amer M. M. Development and validation of a reversed phase HPLC method for simultaneous determination of antidiabetic drugs alogliptin benzoate and pioglitazone HCl. Der Pharmacia Sinica. 2016;7(2):32–40.10.1155/2018/1902510

  • Y. Zhou, W. Zhou, L. Sun, Q. Zou, P. Wei and P. O. Yang, Characterization of Process-Related Impurities Including Forced Degradation Products of Alogliptin Benzoate and the Development of the Corresponding Reversed-Phase HighPerformance Liquid Chromatography Method, J. Sep. Sci., 37(11), 1248-1255 (2014).

  • 1002/jssc.201301384 10. Hani Naseef, Ramzi Moqadi, and Moammal Qurt. Development and Validation of an HPLC Method for Determination of Antidiabetic Drug Alogliptin Benzoate in Bulk and Tablets 2018;4(3) | https://doi.org/10.1155/2018/1902510

  • Williams DA, Lemke TL, editors. Foye’s Principles of Medicinal Chemistry. 7th edition Philadelphia: Lippincott Williams and Wilkins, Baltimore: Wolters and Kluwer Business;2013:1283 https://creighton.pure.elsevier.com/en/publications/foyes-principles-of-medicinal-chemistry-seventh-edition

  • Suchita VG, Varsha M, Jadhav and Vilasrao JK High pressure liquid chromatographic method development and validation for estimation of Alogliptin in bulk and marketed formulation. International J.of pharmaceutical sciences and research 2016;7(5):2194-2199. RP-HPLC, Alogliptin benzoate, Glibenclamide, Validation.

  • Indian Pharmacopeia 2007. Vol. II: 376.


Abstract Views: 261

PDF Views: 0




  • Development and Validation of Rp-hplc Method for the Estimation of Alogliptin in Api and Tablet Formulation

Abstract Views: 261  |  PDF Views: 0

Authors

Suyash Ingle
D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India
Varsha Tegeli
D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India
Avinash Birajdar
D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India
Gajanand Nangare
D.S.T.S. Mandal’s College of Pharmacy, Solapur - 413004, Maharashtra,, India

Abstract


The analytical method was developed and validated for determination of Alogliptin in bulk and pharmaceutical dosage forms by High performance liquid chromatography. The separation was carried out on Zorbax SB-Aq (250 x4.6mm,5μ ID) column. The mobile phase consists of 0.1% TFA Water : ACN in the ratio 62:38 at flow rate 1ml/min with diode array detector wavelength at 290nm.The column temperature was adjusted at 30º ± 0.5°C with injection volume 10μl.The retention time of Alogliptin was 3.06min. The linearity of the calibration curve was linear over the concentration range 25-75μg/ml (r2=1). The validation was carried out as per ICH guidelines. The development of method was easy, rapid, linear, precise, accurate and consistent.

Keywords


Alogliptin, RP-HPLC, Validation, Method development, 290nm and diode array detector.

References