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Development of Validated Stability Indicating RP-HPLC Method for Amisulpride Injection

Deore . T.N., Pawar S.S, Bachhav P.M.

Abstract


Objective of the present work is to develop and validate a simple, cost effective, sensitive and fast RPHPLC method for the analysis of Amisulpride injection. A Waters HPLC system with Octacysilane 150 mm × 4.6 mm column is employed for the analysis using pH 4.5 phosphate buffer solution, acetonitrile and methanol in the ratio of (75:20:5 v/v) as mobile phase. Signal from Amisulpride is detected at 280 nm by UV Spectrophotometer. The proposed method is fully validated and found to be linear over a workable drug concentration, accurate, precise and robust. This is fast and inexpensive method and also this method is Equivalent to UPLC. It is suitable for research laboratories as well as for quality control analysis in pharmaceutical industries.


Keywords


Amisulpride, RP-HPLC, Waters system, Validation, Spectrophotometer

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References


Beckett AH, Stenlake JB. Practical Pharmaceutical Chemistry. Part-2. 4th Edn. New Delhi, India: CBS Publishers and Distributers. 2007; 149–152.

Sharma BK. Instrumental Methods of Chemical Analysis. 13th Edn. India: Goel Publishing House; C3–C20 and C286–C385pp.

Chatwal GR, Anand SK. Instrumental Methods of Analysis. 5th Edn. India: Himalaya Publishing House; 2010; 2.566–2.587 and 2.624–2.639.

West DM, Skoog DA. Fundamentals of Analytical chemistry. Japan: Holt Saunders; 1982; 187.

Singh H, Kapoor VK. Medicinal and pharmaceutical chemistry. 2nd Edn. India: Vallabh Prakashan; 2003; 328.

Watson GD. Pharmaceutical Analysis. 2nd Edn. Elsevier Churchill Livingstone; 2005; 141–149.

Mohr Mary E. Remington: The science and practice of pharmacy. 21st Edn. 351, West Camden Street, USA.

Sharma YR. Introduction of Organic Spectroscopy. 4th Edn. New Delhi, India: CBS Publishers, 1991; 22.

Schimer RE. Modern methods of Pharmaceutical analysis. Vol. 1. 6th Edn. 2002; 31–33.

Sethi PD. HPLC–Quantitative Analysis of Pharmaceutical Formulations. New Delhi, India: CBS Publishers and Distributers. 2001; 116–136.

Lindsey S. High Performance Liquid Chromatography. Analytical Chemistry by Open Learning. 2nd Edn. New York: John Willey; 1987; 17–36, 118–145, 274–281.

Skoog DA, West DM. Fundamentals of analytical chemistry. Japan: Holt Saunders; 1982; 187.

Ahuja S, Rasmussen H. HPLC Method Development for Pharmaceuticals. Separation Science and Technology. Vol. 8. London: Elsevier; 2007; 13–43.

Lyoyd RS, Joseph JK, Joseph LG. Practical HPLC Method Development. Vol. 2. 2nd Edn. Wiley; 2003; 453.

James S, James B. Encyclopedia of pharmaceutical Analysis. Vol. I, 3rd Edn. New York: Marcel Dekker Inc.; 1998; 217–224.

Swartz M, Krull IS. Analytical Method Development and Validation. New York: Marcel Dekker; 1997; 53–67.

Shabir GA. Validation of HPLC Chromatography Methods for Pharmaceutical Analysis. Understanding the Differences and Similarities between Validation Requirements of FDA, the US Pharmacopeia and the ICH. J Chromatogr A. 2003; 987(1–2); 57–66.

Scott RPW. Liquid Chromatography for the Analyst. Chromatographic Vol. 67. New York: Marcel Dekker; 1994; 15–48.

CDER. Review Guidance. Validation of Chromatographic Methods. CDER; Nov 1994.

Mayuresh Kiran, Chandalia HB. Teneligliptin-The Newest DPP4 Inhibitor. Int J Pharma Bio Sci. 2017; 8(2): 163–178.

Luhar Shailesh V. Simultaneous Estimation of Teneligliptin Hydrobromide Hydrate and its Degradation Productby RP-HPLC Method. J Pharm Sci Biosci Res. 2016; 6(3): 254–261.

Sandeep Kharkar. Teneligliptin-the new DPP4 Inhibitor for Type 2 Diabetis. Vidarbha Journal of internal medicine (VJIM). 2016; 21: 34–37.

Hemke Atul T, Rathod EA. Hplc and uv-spectrophotometric estimation of teneligliptin from Tablet dosage form. Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry (AJPAMC). 2016; 4(3): 148–156.

Saraswathi K. Stability indicating RP_HPLC method for development And Validation of Teneligliptin Hydrobromide Hydratein pure and tablet forms. Department of chemistry, Acharya Nagarjuna University, Andhra Pradesh, India. 2016.

Lakshmi Prasana. Spectrometric Assay of Teneligliptin in pharmaceutical Tablet dosage form by ion pair complex method using Bromophenol blue. World J Pharm Pharm Sci. 2017; 6(5): 1156–1166.

Raja Haranadha Babu Chunduri. Development and validation of lc-ms/ms method for quantification of teneligliptin in human plasma and its application to a pharmacokinetic study. World J Pharm Pharm Sci. 2016; 5(5): 838–850.

Nita Yadav. Method development and validation of Teneligliptinin pharmaceutical dosage form by UV spectrophotometric methods. International Journal of Pharmaceutical Chemistry and Analysis (IJPCA). 2017; 4(3): 54–58.

Patil Manish D. Development and Validation of Analytical Method for Simultaneous Estimation of Metformin Hydrochloride and Teneligliptin Hydrobromide Hydratein Pharmaceutical Dosage Form. J Pharm Sci Bio-sci Res. 2017; 7(2): 200–208.

Shah Dimal A. Stability Indicating HPTLC Method for the Estimation of Anti-diabetic Drug Teneligliptin. Curr Pharm Anal. 2017; 13(6).

International Conference on Harmonization. Q2B: Validation of Analytical Procedures: Methodology; Availability. Federal Register (FR). 1997; 62(96): 2463–2467.

International Conference on Harmonization. Q2A: Texton Validation of Analytical Procedures. Federal Register (FR). 1995; 60(40): 11260–11262.


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