Title:An RP-HPLC Method for Quantitative Analysis of Linagliptin Entrapped in Nanotransfersomes and its Application to Skin Permeation Studies
VOLUME: 17 ISSUE: 2
Author(s):Malleswara Rao Peram*, Sachin R. Patil, Vijay M. Kumbar, Manohar S. Kugaji, Kishore G. Bhat, Prakash V. Diwan and Sunil Jalalpure
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
Keywords:Reversed phase-HPLC, transfersomes, linagliptin, in vitro skin permeation, entrapment efficiency, diabetes
mellitus.
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-HPLC method 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 wavelength 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 the 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.
