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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

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  5. 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.

  1. 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.
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  3. 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.
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  5. 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.
  6. https://www.tga.gov.au/sites/default/files/auspar-lurasidone-hydrochloride-140620-pi.pdf.

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Dr Anu Jindal
Corresponding author

GHG Khalsa College of Pharmacy, Gurusar-sadhar, Ludhiana, Punjab 141104

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Simranjeet Singh
Co-author

GHG Khalsa College of Pharmacy, Gurusar-sadhar, Ludhiana, Punjab 141104

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Muskan Sood
Co-author

GHG Khalsa College of Pharmacy, Gurusar-sadhar, Ludhiana, Punjab 141104

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Rajmeet Singh
Co-author

GHG Khalsa College of Pharmacy, Gurusar-sadhar, Ludhiana, Punjab 141104

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Satvinder Kaur
Co-author

GHG Khalsa College of Pharmacy, Gurusar-sadhar, Ludhiana, Punjab 141104

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Jaswinder Singh
Co-author

GHG Khalsa College of Pharmacy, Gurusar-sadhar, Ludhiana, Punjab 141104

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Shaveta Bhardwaj
Co-author

GHG Khalsa College of Pharmacy, Gurusar-sadhar, Ludhiana, Punjab 141104

Simranjeet Singh, Muskan Sood, Anu Jindal*, Rajmeet Singh, Satvinder Kaur, Jaswinder Singh, Shaveta Bhardwaj Analytical Method Validation of Tablet Dosage Form of Lurasidone HCl, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 240-245. https://doi.org/10.5281/zenodo.10113218

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