ABSTRACT:
Analytical method development and validation for estimation of Calcium Dobesilate and Docusate Sodium in Pharmaceutical dosage form with QbD approach. Combination of Calcium Dobesilate and Docusate Sodium helps for the treatment of Haemorrhoid. There is no any UV spectroscopy method of this combination due to less absorbance of the Docusate Sodium in various solvent. A specific, precise and accurate RP-HPLC method has been developed and validated for estimation of Calcium Dobesilate and Docusate Sodium in Capsule dosage form. Apply QbD approach by using statistical tool Design of experiment with Box-Behnken design for the optimization of the screening method of RP-HPLC method. Calcium Dobesilate and Docusate Sodium were estimated on Thermoscientificsyncronis C18 (250mm X 4.6mm), 5µm column using Acetonitrile: 0.01M Tetrabutylammonium dihydrogen phosphate pH-4.8(66:34, v/v) as mobile phase with flow rate 1.0 ml/min and detection was carried out at 214 nm. The retention time of Calcium Dobesilate and Docusate Sodium were found to be 2.943 min and 4.190 min respectively. The linearity and range was found to be 50-450 µg/mL for Calcium Dobesilate and 10-90µg/mL for Docusate Sodium. % RSD of precision was found to be less than 2%. %RSD for Robustness parameters was found to be less than 2%. % Recovery of Calcium Dobesilate and Docusate Sodium at different levels were found in the range of 99.451% - 100.082% and 98.071% - 101.187% respectively. So, the developed method was precise, robust and accurate. The assay value for Calcium Dobesilate and Docusate Sodium was found to be 99.772% - 99.874% and 98.159% - 98.736% respectively.
Cite this article:
Jaydeep S Chauhan, Ritika Gajre. Analytical method development and validation for Estimation of Calcium Dobesilate and Docusate Sodium in Pharmaceutical dosage form with QbD approach. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(3):213-9. doi: 10.52711/0975-4377.2021.00038
Cite(Electronic):
Jaydeep S Chauhan, Ritika Gajre. Analytical method development and validation for Estimation of Calcium Dobesilate and Docusate Sodium in Pharmaceutical dosage form with QbD approach. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(3):213-9. doi: 10.52711/0975-4377.2021.00038 Available on: https://rjpdft.com/AbstractView.aspx?PID=2021-13-3-9
REFERENCE:
1. Kasture AV., Wadodkar SG., and Mahadik KR. Introduction to Instrumental Techniques; 12th Edn; Nirali Prakashan, Pune, 2002, pp 1-3.
2. Skoog DA., Holler FJ., and Nieman TA. An Introduction to Analytical Chemistry; 5th Edn; Thomson Brooks/Cole Publication, Singapore, 1994, pp 566-568.
3. International conference on harmonization, “Guidelines Q8 Pharmaceutical development” http//ich.org/products/guidelines/quality/article/quality- guidelines.html
4. Chatterjee S. , “QBD consideration for analytical methods-FDA perspective”, http://www.fda.gov/downloads/AboutFDA/centersOffices/OfficeofMedicalProducts and Tobacco/CDER/UCM359266.pdf
5. Indian Pharmacopoeia; 7Th Edn(2); Indian Pharmacopoeia Commission, Ghaziabad, 2014, pp 1250-1251.
6. Indian Pharmacopoeia; 7Th Edn(1); Indian Pharmacopoeia Commission, Ghaziabad, 2014, pp 183
7. Indian Pharmacopoeia; 7Th Edn(2); Indian Pharmacopoeia Commission, Ghaziabad, 2014, pp 1610-1611.
8. United State Pharmacopoeia; USP 32 NF 27(2); United State Pharmacopeia convention, 2008, pp 2006-2007.
9. “Marketed Formulation”, July 2014 http://www.medicineindia.org/medicine-brand-details/9100/smuth-capsule
10. “Marketed Formulation”, July 2014 http://www.medindia.net/drug-price/docusate-combination/swift.htm.
11. British Pharmacopoeia; medicine and health care products regulatory Agency, Volume 1, 2010, pp 327.
12. British Pharmacopoeia; medicine and health care products regulatory Agency, Volume 1, 2010, pp 710.
13. “Detection of calcium dobesilate in calcium dobesilate capsules: a comparison of HPLC and UV spectrophotometry.” J. of Medicine and Hygiene. 2009.
14. Rona K., Ary K., “Determination of calcium dobesilate in human plasma using ion- pairing extraction and high-performance liquid chromatography.” Journal of Chromatography. 2001, 755, 245-251.
15. Hepsebah NJR., Nihitha D., Padma P., “RP-HPLC method development and validation for the simultaneous quantitative estimation of Troxerutin and Calcium Dobesilate in tablet” Intenational J. Pharm. Science. 2014, 6(1), 333-339.
16. Hepsebah NJR., Nihitha D., Padma P., “RP-HPLC method development and validation for the simultaneous quantitative estimation of Troxerutin and Calcium
17. Hoque DR., Zimmardi JA., Shah KA., “HPLC analysis of docusate sodium in soft gelatin capsules” J Pharm Science. 1992, 81(4), 359-361.
18. Chandratreya P., Mahajan H., “Development of simple and rapid method for estimation of low levels of docusate sodium from equipment surfaces” International J. of chem. tech. research. 2014, 6(14), 5680-5686.
19. The Merck Index; 14th Edn; Merck Research Laboratories, 2006, pp 3406.