Development & quantitative analysis of validated stability-indicating analytical method for estimation of valsartan and hydrochlorothiazide by high performance thin layer chromatography. (2022)

• Record Type: Journal Article
• Authors: Shewale, Sunil; Undale, Vaishali; Shelar, Maruti; Bhalchim, Vrushali; Panchal, Chandramohan; Gundecha, Sachin
• Is Part Of: Materials today. Volume 51:Part 8(2022)
• Page Start: 2163
• Page End: 2171
• Publication Date: 2022
• Subjects: Valsartan -- Hydrochlorothiazide -- Stability indicating method -- HPTLC etc; Materials science -- Congresses -- Periodicals; 620.1
• DOI: 10.1016/j.matpr.2021.10.476
• Languages: English
• ISSNs: 2214-7853

Abstract

Abstract: An HPTLC technique for simultaneous estimation of Valsartan and Hydrochlorothiazide in a pharmaceutical combination dose form must be verified for stability indication. For the separation of VAL and HTZ using TLC plates coated with aluminium supported silica gel 60 F254, a high-performance thin layer chromatographic (HPTLC) technique has been devised. For the separation of two medicines, a variety of mobile phases were tried and tested. It was decided to use chloroform: ethyl acetate: ethanol/tetrahydrofuran as the final mobile phase for analysis. 247 nm was chosen as the detecting wavelength for both compounds since it exhibited highest absorption. As per the ICH recommendations, the devised technique was validated. Under varied stress settings, medicines were forced to degrade, and the stability of pharmaceuticals was assessed using the HPTLC technique. The separation of VAL and HTZ using HPTLC was a great success. A low percent RSD was determined by testing a variety of factors, and the stability experiments showed that the medicines and degraded products could be separated with an acceptable percent drug recovery profile. Rapid, accurate, and reproducible are some of the characteristics of the devised technique, which proves its appropriateness for valsartan and hydrochlorothiazide stability assessment.