Study of Forced Degradation Behaviour on Some Novel Anti Hypertensive and Anti Retroviral Drugs by Spectrophotometric and RP UPLC and Development of Stability Indicating Method

Abstract

In the present research study a new analytical method has been developed by RP-UPLC and UV-Spectroscopy for the selected pure drug and formulations. Many conventional analytical methods such as RP-HPLC, HPTLC and LC-MS were reported in literatures for the selected drugs. Based on the literature review a novel method developed by RP-UPLC and stability indicating by UV-Spectroscopy. In the developed RP-UPLC methods the retention time for all the selected drugs was found to be below 3.0.The novel, simple, accurate, specific and sensitive method was developed by UV-Spectroscopy and RP-UPLC with TUV and PDA detector. The isocratic elution technique was successfully implemented for the estimation of the selected antiretroviral and anti-hypertensive drugs for both pure drugs and formulations. The developed method was validated using ICH guidelines and also forced degradation studies were performed for the quantification of the selected drugs. The assay was superior when compared to reported methods with respect to sensitivity, rapidity and matrix effect. As a result of forced degradation studies, it may be possible to improve the quality of the pharmaceutical products especially in the areas of formulation, packaging and storage of active pharmaceutical ingredients. Finally, the developed method can be used for the routine analysis of single, double and four drug combinations in regular drug analysis. The outcome of the study reveals that the method developed and validated by RP-UPLC and UV-Spectroscopy for the proposed anti-retroviral and antihypertensive drugs are simple, accurate, precise and economical. The forced degradation studies performed as per ICH guidelines and the values obtained were within the limit. The method developed for the selected compounds found to be unique and in future the following studies were performed; 1. Invitro dissolution studies can be carried out for the selected drugs. 2. LC-MS/MS can be used to determine the degradation pathway of the selected anti-hypertensive and anti-retroviral drugs.