DOI: 10.21276/ajptr
Sun, 21 Jul 2019

Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Determination of Baclofen

Vaibhav Suresh Adhao1*, Raju Ramesh Thenge1

1.Dr. Rajendra Gode College of Pharmacy, Malkapur. Maharashtra, India - 443101


A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of Baclofen. In the present study, stress testing of Baclofen was carried out according to ICH guidelines Q1A (R2). Baclofen was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Extensive degradation was found to occur in acidic, condition. Mild degradation was observed in basic and at thermal conditions. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250 mm × 4.6 mm, 5.0 μ particle size) using acetonitrile: acetate buffer (pH 3.7 ± 0.05) (50:50 v/v), at a flow rate of 1.0 mL/min and column was maintained at 40˚C. Quantification and linearity was achieved at 272 nm over the concentration range of 5 - 100 μg/mL for Baclofen. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.

Keywords: Stability-indicating, HPLC, Baclofen, Validation, Stress Testing.

[PDF]   Viewed: 838   Downloaded: 161
  • Call for paper

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



  • Email & SMS Alerts

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


  • 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.


web counter
web counter