Development and Validation of Spectrophotometric and Chromatographic Method for the Estimation of Apremilast in Bulk and Formulations

  • Pallavi Badhe Department of Quality Assurance Techniques, KCT’S R.G. Sapkal College of Pharmacy Anjaneri, Nashik, India
  • Smita Aher Department of Pharmaceutical Chemistry, KCT’S R.G. Sapkal College of Pharmacy Anjaneri, Nashik, India
  • Ravindranath B. Saudagar Department of Pharmaceutical Chemistry, KCT’S R.G. Sapkal College of Pharmacy Anjaneri, Nashik, India

Abstract

Objective: Objective of the present analytical research work was to develop and validate Spectrophotometric method and High Performance Liquid Chromatographic method (HPLC Method) for the Apremilast bulk and tablets dosage form.


Methods: A spectrophotometric method and a HPLC method have been developed and validated for estimation of APR in pharmaceutical oral dosage form.


Method A (UV SPECTROMETRY Method): The stock and working standard solutions of the drugs were prepared in methanol. Standard solutions were scanned over the range of 400-200 nm in spectrum mode of spectrophotometer at medium scanning speed using UV spectrophotometer. The maximum absorbance for Apremilast was found at 230 nm.


Method B (HPLC Method): The HPLC Method for Apremilast was developed using Cosmosil C18 (4.6mm x 250mm, Particle size: 5µm), as stationary particle, isocratic mode. Methanol: Water (80:20v/v) pH3 as mobile phase. Mobile phase was maintained at a flow rate of 0.8 ml/min and detection was carried out at 230 nm. Both the methods were validated in accordance with ICH guidelines


Results: Apremilast was found to be linear in the concentration range of 2-10 µg/ml for spectrophotometric method and 10-50 µg/ml for HPLC method. Retention time was found to be 4.0 min for Apremilast. The amount of Apremilast in marketed formulation by spectrophotometric method was found to be 99.82 %, the amount of Apremilast in marketed formulation by HPLC method was found to be 99.98 %.


Interpretation and Conclusion: Results of assay and validation study were found to be satisfactory. So, the methods can be successfully applied for the routine analysis of Apremilast.


Keywords: HPLC, bulk dosage form, tablets,

Downloads

Download data is not yet available.

References

1. ICH, Q2 (R1); Validation of Analytical Procedure: text and methodology. International Conference on Harmonization, Geneva, 2005; 1-13.
2. Beckett AH and Stenlake JB. Practical Pharmaceutical Chemistry, Part-II, 4th Ed., New Dehli; CBS Publishers and Distributors, 2004; 85- 174.
3. Willard HH, Merrist LL, Dean AJ, Frank A and Settle AF. Instrumental Methods of Analysis, 7th Ed., New Dehli; CBS Publishers and Distributors, 1986; 2-3, 585-587
4. Skoog DA, Holler FJ and Nieman TA. Principle of Instrumental Analysis, 5th Ed., Thomson Publication Limited, London, 2004; 103.
5. Sethi PD., High Performance Liquid Chromatography, Quantitative Analysis of Pharmaceutical Formulations, 1st edition, New Delhi; CBS Publishers and Distributors, 2001; 3-11, 116-120.
6. Toomula N, Kumar A, Kumar S, Bheemidi VS. Development and Validation of Analytical Methods for Pharmaceuticals & Bioanalytical Techniques, 2011; 2(5): 1-4.
7. Lakshmi SRP. A Review on Chromatography with High Performance Liquid Chromatography (HPLC) and its Functions. Research and Reviews: Journal of Pharmaceutical Analysis, March 2015; 4(1):1-15.
8. Swartz ME. HPLC: An introduction and review. J Liq Chromatogr Rel Technol. 2005; 25:1253–63.
9. Panchumarthy R, Shaheem S, Kamma HS, Development and Validation of a Stability-Indicating Reversed Phase Hplc Method for Determination of Apremilast in Bulk and Pharmaceutical Dosage Form, Der Pharmacia Lettre, 2017; 9 [6]:63-73.
10. Lonkar NA, Sawant SD, Dole MN, Development and validation of stability indicating rp-hplc method for estimation of Apremilast by forced degradation studies, wjpps, 6(4):1493-1502.
11. Rele RV, Patil SP, Reversed Phase High Performance Liquid Chromatography Method for Determination of Assay and Forced Degradation Study of Apremilast from Active Pharmaceutical Dosage Form, Journal of Chemical and Pharmaceutical Research, 2018; 10(7):139-144.
12. Panchumarthy R, Sulthana MDS, Srinivasa Babu P, Development and validation of stability-indicating UV spectrophotometric method for determination of Apremilast in bulk and pharmaceutical dosage form, Indian Journal of Research in Pharmacy and Biotechnology, 2017; 5(1):47-53.
13. Chakravarthy AV, Sailaja BBV, Praveen KA, method development and validation of uv-visible spectroscopic method for estimation of assay of sugammadex sodium, Apremilast, riociguat and vorapaxar sulfate drugs in active pharmaceutical ingredient form, Asian J Pharm Clin Res, 2017; 10(2):241-250.
Statistics
84 Views | 81 Downloads
How to Cite
1.
Badhe P, Aher S, Saudagar RB. Development and Validation of Spectrophotometric and Chromatographic Method for the Estimation of Apremilast in Bulk and Formulations. JDDT [Internet]. 15Dec.2019 [cited 31Oct.2020];9(6-s):136-42. Available from: http://www.jddtonline.info/index.php/jddt/article/view/3777