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STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF CAPMATINIB IN BULK AND TABLET DOSAGE FORM

Authors

  • Suresh Dhone Student
  • S.K. Parjane Assistant Professor
  • Mayur Bhosale Assistant Professor

DOI:

https://doi.org/10.5281/zenodo.8017672

Keywords:

Capmatinib, RP-HPLC, Method Development, Validation

Abstract

The stability indicating method was developed and validated for estimation of Capmatinib. The mobile phase was consisting of Acetonitrile : methanol (60:40).The linearity range of  Capmatinib was found to be 2-10μg/ml. The calibration curve was plotted and regression equation of Capmatinib was found to be y = 791970x + 4780.7 with correlation coefficient (r 2 ) of 0.9993. Detection was done at 252 nm and the retention time of Capmatinib was found to be 3.8 min with the flow rate of 1.0 ml/min. From accuracy study % recovery of Capmatinib was found in the range of 98.89-100.29 % which is in the limits accordingly the ICH guidelines. The method was found to be simple, linear, rapid, accurate, precise, reproducible and robust. The % RSD was found within limit as per ICH guidelines. The result showed that proposed chromatographic method was suitable for the accurate, precise and rapid determination of Capmatinib in its bulk form and pharmaceutical dosage form.

 

 

The stability indicating method was developed and validated for estimation of Capmatinib. The mobile phase was consisting of Acetonitrile : methanol (60:40).The linearity range of  Capmatinib was found to be 2-10μg/ml. The calibration curve was plotted and regression equation of Capmatinib was found to be y = 791970x + 4780.7 with correlation coefficient (r 2 ) of 0.9993. Detection was done at 252 nm and the retention time of Capmatinib was found to be 3.8 min with the flow rate of 1.0 ml/min. From accuracy study % recovery of Capmatinib was found in the range of 98.89-100.29 % which is in the limits accordingly the ICH guidelines. The method was found to be simple, linear, rapid, accurate, precise, reproducible and robust. The % RSD was found within limit as per ICH guidelines. The result showed that proposed chromatographic method was suitable for the accurate, precise and rapid determination of Capmatinib in its bulk form and pharmaceutical dosage form.

Author Biographies

Suresh Dhone , Student

Department of pharmaceutical chemistry, Pravara rural college of pharmacy, Loni, Ahmednagar, Maharashtra, India.

S.K. Parjane, Assistant Professor

Department of pharmaceutical chemistry, Pravara rural college of pharmacy, Loni, Ahmednagar, Maharashtra, India.

Mayur Bhosale, Assistant Professor

Department of pharmaceutical chemistry, Pravara rural college of pharmacy, Loni, Ahmednagar, Maharashtra, India.

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Published

06/25/2022

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How to Cite

1.
Dhone S, Parjane S, Bhosale M. STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF CAPMATINIB IN BULK AND TABLET DOSAGE FORM . ijcrips [Internet]. 2022 Jun. 25 [cited 2024 Apr. 20];1(1):29-36. Available from: https://ijcrips.com/index.php/files/article/view/10

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Original Research Articles