DOI: 10.21276/ajptr
Thu, 18 Oct 2018

Validation of Stability-Indicating Reverse Phase HPLC Method for the Determination of Related Substances in Dapagliflozin Drug Substance

Goutam Sen1*, K. Raghu Babu 2, N. Annapurna 2, N.A.Vekariya1, Vundavilli Jagadeesh Kumar 1*, K.S.R. Pavan Kumar 1 and Hemant Kumar Sharma1

1 Analytical Research Department, Aurobindo Pharma Limited Research Centre-II, Indrakaran (V), Kandi (M), Sangareddy District-502329, Telangana, India.

2 Department of Engineering Chemistry, Andhra University, Vishakapatnam-530003, Andhra Pradesh, India.


ABSTRACT

A gradient reversed phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for the determination for related substances of Dapagliflozin drug substance. Chromatographic separation of Dapagliflozin from its process and degradation related substances was achieved on YMC Pack Pro C18, 250mm × 4.6mm 5m i.e A stainless steel column 250 mm long, 4.6 mm internal diameter filled with Octadecyl silane chemically bonded to porous silica particles of 5 mm diameter maintained column oven temperature at 25°C. Orthophosphoric acid buffer is mobile phase A and acetonitrile is mobile phase B. Wavelength for UV detection: 225nm, flow rate: 0.8 ml/min and Injection volume: 20µl. The developed method suitability was checked and validated as per ICH guidelines for specificity, linearity, accuracy, precision, limit of quantification, limit of detection robustness and ruggedness experiments. Dapagliflozin drug substance was subjected to stress conditions of thermal, hydrolysis, humidity, peroxide and photolytic to observe the degradation products. Limit of detection of each RS is less than 0.008%w/w indicating that the developed method is highly sensitive. The experiment results are given in detailed in this research article.

Keywords: Dapagliflozin, Related substances, HPLC, Validation

 


[PDF]   Viewed: 7   Downloaded: 10 DOI No: 10.21276/ajptr.2018.08.05.26
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.

    Read more...

     

  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.

    Read more...

  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.

    Read more...

web counter
web counter