Method to Develop and Stress Degradation Profile of N-(2,6-dimethylphenyl)-2-{[5-(1H-indol-3-ylmethyl)-1,3,4-oxadiazol-2-yl]sulfanyl}Acetamide Studied by UV Spectroscopy

Background: Synthetic chemistry has always served as a back bone to the medicinal and pharmaceutical chemistry in terms of drug development and drug optimization. It helped in a great deal in finding new lead compounds and synthesizing new drugs. A new molecule N-(2,6-Dimethylphenyl)-2-{[5-(1H-indol-3-ylmethyl)-1,3,4-oxadiazol-2-yl] sulfanyl} acetamide, was synthesized from the fusion of Indole acetic acid with 1,3,4-oxadiazole. This pharmacologically active entity lacks a suitable method for its analysis.

Aim: The present research aimed to develop a UV visible spectroscopic method for the purpose followed by its validation according to ICH guidelines.

Methodology: The method was developed at 225 nm (λmax). Then the accuracy, precision, sensitivity (Limit of detection & Limit of quantification), specificity, robustness and ruggedness were calculated. The analyte was exposed to multiple stress conditions to figure out method’s specificity. Results: The developed method showed the linearity within a range (0.5 – 50 µg/mL) with correlation coefficient (R2) = 0.9997. The accuracy of the developed method was figured out by recovery analysis and it was within 95.556 – 104.321 %. The precision analysis i.e. interday (0.505591 %), intraday (0.231661 %) and repeatability (0.06478 %), were within the acceptance criteria viz. % RSD less than 2 % and LOD & LOQ were found to be 0.523356 and 1.58598 µg/mL. All the validation parameters were within the acceptance limits making the method unique and acceptable. In addition to that it was found to be easy, reliable and analyst friendly (ruggedness, 0.520889 %). The analyte when exposed to stress conditions viz. acidic (0.1N H2SO4) and basic (0.1N NaOH) environment, oxidative stress (3 % H2O2), UV light and altered temperature and humidity (80 ºC+75% RH) for 24 hr, it was found deteriorated. The analyte was 65.56 % degraded in acidic, 39.63 % in basic, 45.18 % under oxidative stress and 61.85 % under altered conditions of temperature and humidity. There was a complete loss of analyte (87.78 %) when exposed to UV light.

Conclusion: The results clearly states that the method is simple, sensitive, specific, precise and accurate, thus can be employed for the quantitative estimations of the analyte.