Dissolution Method Development and Validation for Estimation of Noscapine Tablets

  • Jigar Vyas Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India
  • Jaydip Solanaki Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India
  • Kapil Daxini Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India
  • Puja Vyas Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India
  • Neha Pal Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India

Abstract

A dissolution method was developed and UV spectrophotometry was developed for the evaluation of the dissolution of tablets containing 15 mg Noscapine .The dissolution medium 0.1 N HCl was found suitable to ensure sink conditions. USP Apparatus 2, 900 mL dissolution medium 45 minutes and 100 RPM were fixed. Dissolution profiles were generated at 10, 15, 20,   30; 45 min. Dissolution samples were analyzed with UV spectrophotometer at 213 nm. The UV method for determination of tablet was developed and validated. The method presented linearity (R2 = 0.999) in the concentration range of 1–9 μg/mL. The recoveries were good, ranging from 97.18% to 101.45%. The intraday and Interday precision results were 0.54% and 0.78% RSD, respectively. The developed dissolution test is adequate for its purpose and can be applied for the quality control of tablets.


Keywords: Dissolution test; Noscapine; Tablets; UV Spectrophotometry method

Keywords: Dissolution test, Noscapine, UV Spectrophotometry

Downloads

Download data is not yet available.

Author Biographies

Jigar Vyas, Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India

Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019   Gujarat   India

Jaydip Solanaki, Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India

Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019   Gujarat   India

Kapil Daxini, Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India

Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019   Gujarat   India

Puja Vyas, Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India

Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019   Gujarat   India

Neha Pal, Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019 Gujarat India

Department of Quality Assurance, Sigma Institute of Pharmacy, Bakrol- Vadodara- 390019   Gujarat   India

References

(1) Breier AR.; Paim CS.; Steppe M.; Schapoval EES. Development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets. J. Pharm. Pharm. Sci. 2005; 8(2):289–298.
(2) British Pharmacopoeia 2011. British Pharmacopoeia Commission, 2011; (1):1573-1575.
(3) European Pharmacopoeia VII. European Directorate for Quality of medicines and Health care, 2011; (2):2529-2530.
(4) Indian Pharmacopoeia, Pharmacopoeia commission-Ghaziabad, Govt of India. Ministry of Health Family Welfare, 2010; (3): 1798-1800
(5) International conference on harmonization of technical requirements for registration of pharmaceutical for human use, validation of Analytical procedure: Text and Methodology ICH Q2 (R1), 2005.
(6) Japanese pharmacopoeia. Ministry of health, labour and welfare, 2009; 936.
(7) Karuppiah SP,” Analytical method development for dissolution release of finished solid oral dosage forms” Int. J. Cur. Pharm. Res., 2012; (4): 48-53.
(8) Kulkarni AP, Shahnawaz M, Zaheer Z, Dehghan MH.” Development and Validation of a Dissolution Method for Pioglitazone Tablets” dissolution technologies, 2012, 36-45
(9) Noscapine September 2015, http://www.drugs.com/international/noscapine.html
(10) Sperandeo NR; Kassuha DE. Development and Validation of a Dissolution Test for 6 mg Deflazacort Tablets. Sci. Pharm. 2009; (77):679–693.
(11) Swartz M. and Emanuele M.,” Developing and Validating Dissolution Procedures for Improved Product Quality” synomicspharma, 2012; 1-12.
(12) Validation of Analytical procedures: Text and methodology, Geneva, 2005.
(13) Shah VP, Lesko LJ, Fan J, Fleischer N, Handerson J, Malinowski H, Makary M, Ouderkirk L, Roy S, Sathe P, Singh GJP, Tillman L, Tsong Y, Williams RL, “FDA guidance for industry: dissolution testing of immediate release solid oral dosage forms”, Dissolution Technol. 1997; (4):15–29
(14) The United States Pharmacopeia and National Formulary USP 27–NF 24; the United States Pharmacopeial Convention, Inc.: Rockville, MD, 2007
(15) United States Pharmacopoeia 35-National Formulary-30, the United States Pharmacopeial Convention Rockville, 2012; 3120.
Statistics
18 Views | 20 Downloads
How to Cite
1.
Vyas J, Solanaki J, Daxini K, Vyas P, Pal N. Dissolution Method Development and Validation for Estimation of Noscapine Tablets. JDDT [Internet]. 15Feb.2020 [cited 31May2020];10(1-s):159-64. Available from: http://jddtonline.info/index.php/jddt/article/view/3891