DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF DOLASETRON MESYLATE

Authors

  • Lahu B. Birajdar Department of Quality assurance, AISSMS College of Pharmacy, Kennedy road, Near RTO, Pune 411001, Maharashtra, India
  • Mrinalini C. Damle Department of Quality assurance, AISSMS College of Pharmacy, Kennedy road, Near RTO, Pune 411001, Maharashtra, India

Keywords:

Dolasetron mesylate, HPTLC, Stability indicating method

Abstract

Objective: To develop and validate stability indicating HPTLC method for determination of Dolasetron mesylate.

Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F254 using Methanol: Choloroform: Ethyl acetate (7:2:1 v/v/v) as mobile phase followed by densitometric scanning at 280 nm.

Results: The chromatographic condition gave a compact spot for Dolasetron mesylate at Rf value of 0.65±0.03. Stress testing was performed in accordance with international conference on harmonization (ICH) Q1A R2 guidelines. Method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 100-800 ng/band for Dolasetron mesylate. The limit of detection and quantification was found to2.24 ng/band and 6.79 ng/band, respectively.

Conclusion: A new sensitive, simple, and stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for determination of Dolastron mesylate. The proposed method can be used for routine determination of Dolasetron mesylate stability.

 

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Author Biography

Mrinalini C. Damle, Department of Quality assurance, AISSMS College of Pharmacy, Kennedy road, Near RTO, Pune 411001, Maharashtra, India

Professor, Department of Quality Assurance

References

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Published

01-07-2015

How to Cite

Birajdar, L. B., and M. C. Damle. “DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF DOLASETRON MESYLATE”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 7, July 2015, pp. 165-70, https://www.innovareacademics.in/journals/index.php/ijpps/article/view/5573.

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