Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF TULOBUTEROL IN TRANSDERMAL DRUG DELIVERY SYSTEM

Kavita Parui* and Dr. Snehalatha Boddu

ABSTRACT

A sensitive, accurate and reproducible RP-HPLC method has been
developed and validated for the determination of Tulobuterol in
transdermal drug delivery system. Chromatographic separation was
achieved isocratically on a Prontosil C18 column (250 x 4.6 mm, 5 μm)
with a mobile phase consisting of Acetonitrile:0.02M Potassium
dihydrogen phosphate buffer (60:40), adjusted to pH 3.0 with
Orthophosphoric acid at the flow rate of 1.0 mL/min. UV detection
was performed at 215 nm. The retention time for tulobuterol was found
to be 2.880 minute. The proposed method was validated by parameters
such as selectivity and specificity, linearity, accuracy, precision, limit
of detection, limit of quantification, robustness and assay according to the ICH guidelines.
The calibration curve of tulobuterol was linear in the range of 25 – 75 μg/mL with correlation
coefficient (r2) of 0.9998. Both intra and inter-day precision and accuracy were within
acceptable limits. The limit of detection and limit of quantification for tulobuterol were found
out to be 2.90 and 0.95 respectively. The robustness was also estimated on the small
fluctuations in the mobile phase compositions, wavelength and the flow rate. The developed
method can be applicable for routine quantitative analysis.

Keywords: Tulobuterol, Transdermal drug delivery, RP-HPLC, Method Validation.