DOI: 10.21276/ajptr
Tue, 25 Jun 2019

Stability Indicating Analytical Method Development and Validation for Estimation of Orlistat in Bulk and its Dosage form by HPTLC Technique and Finding Degradants by LC-MS.

Shekhar Chaudhry*, Rajendra B. Patil

Department of Quality Assurance Technique, Rajarshi Shahu College of Pharmacy & Research, Tathwade Pune-33


A new simple, accurate, precise and selective stability indicating high performance thin layer chromatographic method has been developed and validated for estimation of Orlistat Tablet.T he mobile phase selected was Toluene: Methanol(8:2v/v) with UV detection at 211nm.The retention factor for Orlistat was found to be 0.60±0.02. The method was validated with respect to linearity, accuracy, precision and robustness as per the ICH guidelines. The drug were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in concentration range of 6000-36000 ng/band. The thermal method has been successfully applied for the analysis of drug in pharmaceutical formulation. The % assay (Mean ± S.D) was found to be 99.30±1.10.The developed method can be used for checking the stability of  Orlistst in bulk drug and pharmaceutical dosage form.

Keywords: Forced degradation, High performance thin layer chromatography (HPTLC), Orlistat, stability-indicating method, Validation, High performance thin Liquid chromatography- Mass spectrometry(HPTLC-MS), Degraded products(DP).

[PDF]   Viewed: 287   Downloaded: 78 DOI No: 10.21276/ajptr.2018.08.03.11
  • 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