Analytical Method Validation of Tablet Dosage Form of Lurasidone HCl

Dr Anu Jindal, Simranjeet Singh, Muskan Sood, Rajmeet Singh, Satvinder Kaur, Jaswinder Singh, Shaveta Bhardwaj,

doi:10.5281/zenodo.10113218

Research Paper | Open Access
Volume 01 | Issue 11 | Article Id IJPS/23011112

Analytical Method Validation of Tablet Dosage Form of Lurasidone HCl
Dr Anu Jindal* Simranjeet Singh Muskan Sood Rajmeet Singh Satvinder Kaur Jaswinder Singh Shaveta Bhardwaj
GHG Khalsa College of Pharmacy, Gurusar-Sadhar

Abstract

This research is mainly focused on development of an Excellent Gradient method by reverse phase - high performance liquid chromatography (RP-HPLC) using UV Visible Detector. The main objective of method validation of Lurasidone HCl as a tablet dosage form is to validate the method as in-house method. As this tablet dosage form is not registered in any of Pharmacopeia, so the method is developed and validated for further studies. The sample is analyzed by RP-HPLC using octadecylsilane (C18) column (Inertsil LC-GC) as stationary phase with UV-Visible detector. The ‘Gradient Method’ is used as instrumental method. The Mobile phase (A) was prepared using potassium phosphate buffer by adjusting the pH of value 4.0 and mobile phase (B) was 100?etonitrile; the ratio used for gradient was buffer: acetonitrile (40:60) respectively. The wavelength for ? max was selected by UV-Visible detector on spectrophotometer at wavelength 254nm. This method complies with Linearity , Accuracy , Recovery , Specificity , precision , stability , LOD , LOQ and Robustness

Keywords

Lurasidone, Analytical Method Validation, Reversed Phase HPLC, Dissolution, Assay, and Area vs Concentration

Reference

FDA approves Latuda to treat schizophrenia in adults, USFDA 2010, Retrieved October 29, 2010, http://www.fda.gov/NewsEvents/Newsroom/Press Announcement s/ucm231512.htm.
Joshi NK, Shah JN. Development and validation of RP-HPLC method for estimation of lurasidone hydrochloride: a novel antipsychotic drug in bulk and pharmaceutical dosage form., 2012; 3(4): 2643-2653.
Damodar K, Bhogineni S. RP-HPLC method development and validation for the analysis of lurasidone in pharmaceutical dosage form.DIT., 2011; 3(12): 305-308.
Sudhir MS, Nadh RV. Simple and validated ultraviolet spectrophotometric methods for the estimation of lurasidone in bulk drug. RJPBCS., 2013; 4(1): 609-617.
Joshi NK, Dumasiya MN. Development and validation of spectrophotometric method for

estimation of lurasidone hydrochloride: a novel antipsychotic drug in bulk and pharmaceutical dosage form. IJPS., 2012; 3(4): 2643-2653.

Chhabda PJ, Balaji M. Development and validated of stability indicating method for determination of lurasidone in bulk drug and pharmaceutical dosage form by HPLC.IJPRD., 2013; 5(09): 103-114.
Polawar AR, Damle MC, Development and validation of stability indicating HPTLC Method for quantification of Lurasidone Hcl, Pharma Science Monitor., 2014; 5(3): 131-144.
Chae, Yoon-Jee;Koo,Tae-sung;Lee,Kyeong-Ryoon. A sensitive and selective LC-MS Method for the determination of Lurasidone HCl in rat plasma , Bile, and Urine,Chromatographia, 2012;75:1117-1128.
Mali Nikita, Patel Jignesh, Patel Mandev. Validated Spectrophotometric Methods For The Estimation of Lurasidone Hydrochloride in Bulk And Pharmaceutical Dosage Forms. IJRPS,2012; 2(2): 44-50.
Nirav.K, Joshi, Nehal Shah, Minaxi Dumasiya and Alisha Patel. Development and Validation of spectrophotometric method for estimation of Lurasidone hydrochloride: a Novel antipsychotic drug in bulk and pharmaceutical dosage form. IJPS, 2012; 3(4): 2643-2653.
https://www.tga.gov.au/sites/default/files/auspar-lurasidone-hydrochloride-140620-pi.pdf.