Stability-Indicating HPTLC Method Development and Validation of Flurandrenolide in Api and It's Lotion

Abstract

HPTLC stability indicating method has been developed for determination of anti-psoriasis drug, flurandrenolide in API and its formulation. The method was constructed on high performance thin layer chromatography separation of the drug followed by densitometric measurements of their spots at 238 nm. The separation was carried out on Merck TLC aluminium sheets of silica gel 60F254 using toluene: acetone in the ratio of 6: 4 v/v as a mobile phase. The method was validated in accordance with the requirements of ICH guidelines. Calibration curves were linear in range of 200-1200 ng/µl for flurandrenolide and correlation coefficient of calibration curve was found to be 0.9997 respectively. Limit of detection and limit of quantification were found to be 29.7ng/µl and 90.0ng/µl. Method had an accuracy of 100.09% for flurandrenolide in lotion. The developed simple, accurate, precise, specific and reproducible HPTLC method is successively applied to determine flurandrenolide in its lotion formulation.

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“…The procedures applied in each method do not need any sophisticated instruments, critical reactions or any pretreatment step. The proposed methods are found to be sensitive, selective and accurate with no significant difference of the precision compared with the spectrophotometric reported method [87].…”

“…Recoveries, mean, standard deviation, RMSEC, RMSEP and other validation parameters for ezetimibe in both models were shown in Tables 10 & 11. Tables 12 & 13 shows statistical comparison of the results obtained by the proposed methods and the reported spectrophotometric method [87]. There is no significant difference between the proposed methods and the reported method related to accuracy and precision as the calculated t and F values are less than the theoretical ones and the comparison related to one way ANOVA which applied for each zetamibe® and zetajon® tablets.…”

Bivariate and Multivariate Spectrophotometric Methods for Determination of Ezetimibe with Kinetic Study of Its Alkaline Degradation

“…13 show statistical comparison of the results obtained by the proposed methods and the reported spectrophotometric method. 87 There is no significant difference between the proposed methods and the reported method related to accuracy and precision as the calculated t and F values are less than the theoretical ones and the comparison related to one way ANOVA which applied for each zetamibe® and zetajon® tablets.…”

“…The proposed methods are found to be sensitive, selective and accurate with no significant difference of the precision compared with the spectrophotometric reported method. 87 They could be applied for routine analysis of ezetimibe in pure form or in its pharmaceutical formulation without interference from the excipients or the degradation product and could also be easily used in quality control laboratory for its analysis. The methods are also suitable and valid for application in laboratories lacking liquid chromatographic instruments.…”