Thu, 26 Apr 2018

Method Development and Validation for the Simultaneous Estimation of Pitofenone Hydrochloride, Diclofenac Potassium and Fenpiverinium Bromide In Pharmaceutical Dosage Forms by UPLC

Pulagurtha Bhaskararao1*, Gowri Sankar Dannana1

1.Department of Pharmaceutical Analysis, College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India-530 003.


ABSTRACT

The present study is carried out using the UPLC as the analytical technique in developing and validating an accurate, precise, linear and robust analytical method for the simultaneous estimation of Pitofenone hydrochloride, Diclofenac potassium and Fenpiverinium bromide in tablets. The method is optimized with a mixture of 0.01M phosphate buffer (PH4.8) and Acetonitrile in the ratio of 40:60 (V/V) as mobile phase and Agilent SB C18 (250 X 4.6) mm, 5µm as stationary phase. The Chromatographic peaks were detected and measured at 215nm. The retention times of Pitofenone hydrochloride, Diclofenac potassium and Fenpiverinium bromide were found to be 1.0, 1.66 and 2.0 respectively. The developed method was demonstrated to access its suitability for meeting its intended purpose by the Validation with a set of validation parameters as per ICH and USP guidelines.  The method is found to be precise with %RSD - 0.48, 0.69, 0.66 for Pitofenone hydrochloride, Diclofenac potassium and Fenpiverinium bromide respectively: accurate with the recoveries of 99.6 to 101.6, 100.51 to 101 and about 100% for Pitofenone hydrochloride, Diclofenac potassium and Fenpiverinium bromide respectively. The method is proved to be linear from the conc.12.5 to 75ppm for Pitofenone, 250 to750 ppm for Diclofenac and 0.5 to 1.5ppm for Fenpiverinium bromide with the correlation coefficients of 0.999, 0.999 and 0.999 respectively. Hence the developed method could be used for the routine analysis purpose in the evaluation of Pitofenone, Diclofenac potassium and Fenpiverinium bromide Tablets.

Keywords: Pitofenone hydrochloride, Diclofenac potassium, Fenpiverinium bromide, UPLC, Validation


[PDF]  Viewed: 132  Downloaded: 40
  • 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