Bioanalytical Method Development and Validation and forced degradation of Sitagliptin and determination of Pharmacokinetic application study in Human Plasma by RP-HPLC method

  • Shanthi Diraviyam Shanmuga Kumar Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA https://orcid.org/0000-0002-3360-5829
  • Mahendar Kotte Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA https://orcid.org/0000-0001-5888-6455
  • N Keerthana Rao Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA https://orcid.org/0000-0002-2757-4819
  • Vollem Jyothi Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA https://orcid.org/0000-0003-1231-2629
  • Juttu Pavani Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA https://orcid.org/0000-0001-6006-0425
  • Ashritha Shivani Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA https://orcid.org/0000-0001-8499-2243
  • P Shyam Sundar Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA https://orcid.org/0009-0006-5705-9371

Abstract

In the present investigation, an attempt was made for the development, validation, forced degradation and pharmacokinetic application of sitagliptin in the human plasma spiking studies by UV - HPLC method. The experimentation was developed based on the extensive literature survey and ascertained by the statistical parameters of the sampling. A simplified, accurate method was created by the liquid chromatographic system from Shimadazu LC 20AD consisting of manual injection. The optimized chromatogram was obtained with acetonitrile in the isocratic mobile phase method at a 1.0 mL/min flow rate. A thermo C-8 column (4.6X250mm,5μm) was used as a stationary phase, and 265.0nm was selected as the detection wavelength with the aid of a UV-Vis detector. The proposed method was validated as per ICH guidelines. The technique was linear in the range of 10-50μg/mL with correlation coefficient R2 = 0.9746, respectively. Recovery studies postulated that % RSD 19.14, 3 & 9.95 respectively. Injection repeatability values were found to be % RSD 17 & 10.63 for intraday and interday, respectively. Stress degradation studies revealed that sitagliptin degrades more rapidly when subjected to 0.1 NaoH. Human plasma spiking studies reported 3.02 ng/mL at 3.02+/-60 min of C and T max, respectively.


Keywords: Sitagliptin, Method development, HPLC, Validation, Stress degradation studies, Human plasma spiking studies

Keywords: Sitagliptin, Method development, HPLC, Validation, Stress degradation studies, Human plasma spiking studies

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Author Biographies

Shanthi Diraviyam Shanmuga Kumar, Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Mahendar Kotte, Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

N Keerthana Rao, Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Vollem Jyothi, Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Juttu Pavani, Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Ashritha Shivani, Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

P Shyam Sundar, Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

Department of Pharmaceutical Chemistry & Analysis, Jyothishmathi Institute of Pharmaceutical sciences, Thimmapur (V), R K Colony, Karimnagar - 505527, Telangana State, INDIA

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Kumar SDS, Kotte M, Rao NK, Jyothi V, Pavani J, Shivani A, Sundar PS. Bioanalytical Method Development and Validation and forced degradation of Sitagliptin and determination of Pharmacokinetic application study in Human Plasma by RP-HPLC method. JDDT [Internet]. 15May2024 [cited 17May2024];14(5):11-8. Available from: https://jddtonline.info/index.php/jddt/article/view/6559