Abstract

VALIDATED UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT FOR EVALUATION AND STABILITY ANALYSIS OF TOLVAPTAN IN BULK DRUG AND ITS FORMULATION

Sasikala M.*, Karpakavalli M., Vanathi P., Ranjithkumar D., Prakash G., Mohan S.

ABSTRACT

To develop a validated simple, selective, sensitive, stability-indicating and cost effective UV spectrophotometric method for determination of Tolvaptan (Anti-hypertensive) in bulk and its formulation.The drug exhibited λmax at 260 nm in DMSO (Dimethyl sulphoxide) and distilled water in the ratio of 1:9 v/v. Method validation was executed as per ICH (International Conference on Harmonization) guidelines, optimized, implemented for quantification of formulation and stability testing utilizing forced degradation strategies such as pH, oxidation, temperature and UV light. The optimized specifications for suggested method were linear in the range of 5.0 – 25.0 μg/ml, correlation coefficient, slope and intercept values as 0.999, 0.030 and 0.006 sequentially. The % RSD was <2.0 % reflected precision of the procedure for intraday and interday research. LOD (3:1) and LOQ (10:1) were 0.490 and 1.300 separately. From % recovery exercises (80 %, 100 % and 120 %), Tolvaptan recovered from its tablet formulation was 79.78 %, 99.77 % & 120.44 % respectively. The quantification of formulation reveal that the amount and the percentage of Tolvaptan tablet with label claim 30 mg was perceived as 0.0301 g and 100.33 % independently. As per stress stability experimenting, the drug was established unstable beside oxidation trial and stable in the rest of the examining. Hence, the developed method expressing stability can be adapted for routine analysis of the analyte of interest in educational institutions, research industries and laboratories.

Keywords: Tolvaptan, ICH, UV Spectrophotometry, Method Development, Validation, Forced Degradation.