Analytical method validation and quantification of raloxifene hydrochloride and its related substance in API using reverse phase - liquid chromatographic method
Journal Title: Scholars Academic Journal of Pharmacy - Year 2017, Vol 6, Issue 11
Abstract
The present paper describes the reverse phase-high performance liquid chromatographic method and was validated as per ICH guidelines for the determination of related substances in raloxifene hydrochloride. RP-Liquid chromatography technique was performed with pH 3.0 phosphate buffer and acetonitrile as mobile phase at a flow rate of 1.0 mL/minon Waters 2489 UV 2695 pump, Waters 2998 PDA 2695 pump Software Empower 3, with photodiode array detector using Inertsil BDS C8 250 x 4.6 mm, 5µm column with UV detection at 280 nm. The method is specific and % RSD for system precision were 0.18 and 0.35 for raloxifene hydrochloride and Impurity- A respectively. For Method precision, % RSD for Raloxifene hydrochloride was 0.17 %. Linearity were observed for Raloxifene hydrochloride and Impurity- A, in the concentration range of 0.0006 and 0.0045 were linear (R2 = 0.9999 and R2 = 0.9999) Accuracy is calculated as % recovery. % Recovery for accuracy levels at 50, 100 and 150 % L for Raloxifene hydrochloride and Impurity- A were 103.56 ± 0.19, 114.23 ± 0.36, 107.09 ± 0.61 and 103.51 ± 0.30, 1143.41 ± 0.15, 103.62± 0.26, respectively. Rugedness was performed by different analyst on different days and % RSD between the areas is 0.84 Raloxifene hydrochloride. For Robustness, pH will shown the effect on retention time, hence better to maintain the pH at 3± 0.05. Signal to Noise ratio for Limit of detection and the limit of quantification were found to be in between 3-5 and > 10 for raloxifene hydrochloride and Impurity- A, respectively. The percent recovery was in good agreement; hence, the method is specific, simple, reproducible and accurate for the determination of Raloxifene hydrochloride. Keywords:Raloxifene hydrochloride, estimation of related substances, liquid chromatography and percent recovery.
Authors and Affiliations
Yenisetty Ranganayakulu, Korupolu Raghu Babu, TentuNageswara Rao, AvuthuMuralidhar Reddy
Keywords
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