RP-HPLC Method Development for Estimation of Diclofenac Diethylamine Topical Solution

RP-HPLC Method development and validation of single topical dosage form

DOI:

https://doi.org/10.37285/ijpsn.2023.16.4.4

Authors

  • Sejal H Dhaduk a:1:{s:5:"en_US";s:38:"B. K. Mody Government Pharmacy College";}
  • Nilesh K Patel B.K.Mody Government Pharmacy College, Rajkot, India
  • Jaivik H Modh B.K.Mody Government Pharmacy College, Rajkot
  • Amitkumar J Vyas B.K.Mody Government Pharmacy College, Rajkot, India
  • Ajay I Patel B.K.Mody Government Pharmacy College, Rajkot, India.

Abstract

Objective: A simple, rapid, precise, and reproducible RP-HPLC method development and validation for estimation of Diclofenac Diethylamine in Topical Solution.

Experimental condition: The method was developed using Kromasil C8 (150 mm × 4.6 mm, 5 µm) column. Mobile phase composition was Buffer: Methanol (25:75 %V/V) (Buffer-1.37 g of NaH2PO4 in 1000 ml adjust pH 2.5 ± 0.05 with OPA.), flow rate 1 ml/min and detection carried out at 254 nm at column temperature 40ºC. The injection volume was 10µl with run time of 10 minutes. Diluent used was Methanol: Water (50:50 % V/V).

Results: The retention time for Diclofenac Diethylamine was found 5.26 minute. Method found linear in the range of 50-150 µg/ml (r2 = 0.9998). Percentage Recovery was 100.5-100.9 %. The RSD for Diclofenac Diethylamine are less than 2 for precision, specificity, robustness respectively.

Conclusion: A simple and rapid RP-HPLC method was developed for the estimation of Diclofenac Diethylamine in pure API and Topical formulation. The method was validated as per ICH guideline and statistical data confirmed Specificity, Linearity, Accuracy, Precision and Robustness of proposed method.

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Keywords:

Diclofenac Diethylamine, RP-HPLC, ICH (Q2R1), Topical Preparation, Analysis, Validation

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Published

2023-07-31

How to Cite

1.
Dhaduk SH, Patel NK, Modh JH, Vyas AJ, Patel AI. RP-HPLC Method Development for Estimation of Diclofenac Diethylamine Topical Solution: RP-HPLC Method development and validation of single topical dosage form. Scopus Indexed [Internet]. 2023 Jul. 31 [cited 2024 Nov. 4];16(4):6875-81. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/3038

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Research Articles

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