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
Related Articles
- EP ID EP378361
- DOI -
- Views 137
- Downloads 0
Changes in the Amounts of Amoxicillin and Metronidazole Used for Helicobacter pylori Eradication Therapy in the Stomach after Their Oral Administration to Rats
In the eradication therapy of Helicobacter pylori, the changes of the amounts and concentrations of antibiotics in the stomach after oral administration were unclear. Amoxicillin (AMX) and metronidazole (MTZ), which are...
Alzheimer Disease: Therapeutic Targets & Recent Developments in Treatment
Alzheimer’s disease is characterised by progressive loss of memory which is episodic in nature. Numerous drugs have been utilised for its treatment like cholinesterase inhibitors, NMDA antagonists etc but none of them...
A Zinc Selective Polymeric Membrane Electrode Based on N, N'-benzene-1, 2-diylbis[1-(pyridin-2-yl)ethanimine] as an Ionophore
A Schiff base N, N’-benzene-1, 2-diylbis [1-(pyridin-2-yl) ethanimine] was synthesized and used as ionophore for selective determination zinc ion in various samples. The proposed sensor show good selectivity for zinc (Zn...
Effect of topical anesthetics on pain during needle insertion of maxillary infiltration anesthesia: a systematic review and meta-analysis study
Abstract:Topical anesthetics are frequently used to reduce the pain of the needle insertion administration of topical anesthesia. The aim of this study is to evaluate the effect of topical anesthetics on pain during need...
Development and Evaluation of Polyherbal Tablet from Some Hepatoprotective Herbs
The objective of the present study was to develop and evaluate hepatoprotective polyherbal tablet because designing of oral herbal formulation is still a challenge in modern pharmaceutics and the tablet formulation prese...