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An RP-HPLC Method for Quantitative Analysis of Linagliptin Entrapped in Nanotransfersomes and its Application to Skin Permeation Studies

Author(s):

Malleswara Rao Peram*, Sachin R Patil, Vijay M Kumbar, Manohar S. Kugaji, Kishore G Bhat, Prakash V Diwan and Sunil Jalalpure   Pages 1 - 10 ( 10 )

Abstract:


Background: Linagliptin (LNG) is an oral hypoglycemic agent that acts by inhibiting the enzyme dipeptidyl peptidase - 4 (DPP-4) and reduces blood sugar levels in type-II diabetic patients. To date, the literature presents few analytical methods for the determination of LNG. However, no reversed phase-high performance liquid chromatography (RP-HPLC) method has been reported for the determination of LNG in nanotransfersomes and in vitro skin permeation samples.Objective: The present study involves the development and validation of RP-HPLCmethod to quantify LNG in both nanotransfersomes and in vitro skin permeation and deposition samples.

Methods: The chromatographic analysis was performed on Luna C18 (2) column (250 x 4.6 mm, 5µm particle size) with a mobile phase consisting of a mixture of methanol: 0.2% orthophosphoric acid (50:50, v/v) at a flow rate of 1.0 mL/min, detection wave length of 227 nm, and column temperature of 40 °C.

Results: The method was found to be specific, linear (r2 ≥ 0.999; 2-12 µg/mL), precise at both intra and inter day levels (percentage relative standard deviation; % RSD < 2.00), accurate (percentage recovery 100.21 – 103.83%), and robust. The detection and quantification limits were 0.27 and 0.82 µg/mL, respectively. The mean % entrapment efficiency and cumulative amount of LNG permeated across the rat skin from different transfersomal formulations ranged between 40.78 ± 2.54 % to 52.26 ± 2.15 % and 79.54 ± 16.67 to 200.74 ± 35.13 µg/cm2 respectively.

Conclusion: The method was successfully applied to determine the entrapment efficiency, in vitro skin permeation and deposition behavior of LNG-nanotransfersomes.

Keywords:

Reversed phase-HPLC, transfersomes, linagliptin, in vitro skin permeation, entrapment efficiency

Affiliation:

Central Research Laboratory, Maratha Mandal’s NGH Institute of Dental Sciences and Research Centre, Belagavi, Karnataka 590010, Department of Pharmaceutics, College of Pharmacy, KLE Academy of Higher Education and Research, Belagavi, Karnataka 590010, Central Research Laboratory, Maratha Mandal’s NGH Institute of Dental Sciences and Research Centre, Belagavi, Karnataka 590010, Central Research Laboratory, Maratha Mandal’s NGH Institute of Dental Sciences and Research Centre, Belagavi, Karnataka 590010, Central Research Laboratory, Maratha Mandal’s NGH Institute of Dental Sciences and Research Centre, Belagavi, Karnataka 590010, Central Research Laboratory, Maratha Mandal’s NGH Institute of Dental Sciences and Research Centre, Belagavi, Karnataka 590010, Dr. Prabhakar Kore Basic Science Research Centre, KLE Academy of Higher Education and Research, Nehru Nagar, Belagavi 590010, Karnataka



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