Stability Indicating HPTLC Method for Simultaneous Estimation of Sacubitril and Valsartan in their Pharmaceutical Dosage Form

DOI:

https://doi.org/10.37285/ijpsn.2018.11.4.8

Authors

  • Gopi Patel
  • Arshad Vohra
  • Samir Shah

Abstract

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and completely validated for the estimation of Valsartan and Sacubitril in pharmaceutical dosage forms. Quantification of Valsartan and Sacubitril were carried out with precoated silica gel aluminum Plate 60 F254, (20 cm ×10 cm) 100 μm thickness as stationary phase. Toluene: Methanol: Ethyl Acetate: Glacial Acetic acid (8:2:1:1 % v/v/v). The optimized chamber saturation time before chromatographic development was 20 min at room temperature (25ºC ± 2). The length of chromatographic run was 8 cm which took average 15 min to develop. Densitometry scanning was performed using Camag TLC scanner IV with Win CATS software (V 1.4.6.2002, Camag). Optimized chromatogram of Valsartan and Sacubitril having Rf of 0.43 and 0.33, respectively. Linear relationship between peak area and concentration of standard was evaluated over the concentration range expressed in ng/band by making five replicate measurements in the concentrations range of 400-1400 ng/band and 4000-14,000 ng/band, respectively for Valsartan and Sacubitril. Literature reveals that there was no any method developed using HPTLC in simultaneous estimation of Valsartan and Sacubitril in their pharmaceutical dosage form. The proposed method can be successfully applied for the estimation of drug content of different marketed formulations.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

HPTLC, Stability Indicating Method, Sacubitril, Valsartan

Downloads

Published

2018-07-31

How to Cite

1.
Patel G, Vohra A, Shah S. Stability Indicating HPTLC Method for Simultaneous Estimation of Sacubitril and Valsartan in their Pharmaceutical Dosage Form. Scopus Indexed [Internet]. 2018 Jul. 31 [cited 2024 Nov. 19];11(4):4208-1. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/383

Issue

Vol. 11 No. 4 (2018): July-August 2018

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

References

Bhatia MS and Kokil SU (2009). Determination and validation of Valsartan and its degradation products by isocratic HPLC. J. Chem. Met 3(1): 1-12.
Celebier M, Kaynak MS, Altinoz S, and Sahin S (2010). HPLC method development for the simultaneous analysis of amlodipine and valsartan in combined dosage forms and in vitro dissolution studies. Braz. J. Pharm. Sci 46(4): 761-768.
Ghanty S, Das R, Maity S, and Sen KK (2014). RP-HPLC Method for Estimation of Valsartan in Solid Oral Dosage Forms. J. Pharm. Sci. Tech., 3(2); 88-91
Goyal. R.K. (2009). Element of Human Anatomy and Health Education, 21st, B.S Shah Prakashan, Ahmedabad.
Haque MA, Amrohi SH, Kumar PK, Dibyalochan P, and Diwan PV (2012). Stability indicating RP-HPLC method for the estimation of Valsartan in pharmaceutical dosage form. Int. J. Pharm 2(4): 12-18.
ICH Harmonized Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology, Q2 (R1), Geneva, Switzerland, 2005.
ICH, Validation of Analytical Procedures; Methodology, Q2 (R1), International Conference on Harmonization, IFPMA, Geneva 1996.
Imam SS, Ahad A, Aqil M, Ali A, and Sultana Y (2013). A validated RP-HPLC method for simultaneous determination of propranolol and valsartan in bulk drug and gel formulation. J. Pharm. Bio. Allied Sci 5(1): 61-65.
Kendre MD and Banerji SK (2012). Precise and Accurate RP-HPLC Method Development for Quantification of Valsartan in Tablet Dosage Form, Int. J. Pharm. Sci. and Drug Res., 4(2):137-139.
Kokil SU and Bhatia MS (2009). Simultaneous Estimation of Nebivolol Hydrochloride and Valsartan using RP-HPLC. Ind. J. Pharm. Sci 71(2): 111-114.
Kumaraswamy G, Kumar JM, Rao SJ, and Laxmi SM (2012). Validated RP-HPLC Method For Simultaneous Estimation of Aliskiren and Valsartan in Tablet Dosage Form. J. drug del. And thera 2(5): 162-166.
Kumar PS, Sahu M, Prasad KD, and Shekhar MC (2011). Development and Validation of Analytical Method for the Estimation of Valsartan In Pure And Tablet Dosage Form By RP-HPLC Method, Int. J. Res in Phar. And Chem 1(4): 945-949.
Manoranjani M and Bhagykumar T (2011). RP-HPLC Method for the Estimation of Valsartan in Pharmaceutical Dosage Forms. Int. J. Sci. Inn. Disc 1(2): 101-108.
Nissan Kararao S, Kumar A, Sravanthi A, and Naga SJ (2013). Method development and validation for the estimation of valsartan in bulk and tablet dosage forms by RP-HPLC Der Pharm. Chem 5(2): 206-211.
Parambi DT, Mathew M, and Ganesan V (2011). A validated stability indicating HPLC method for the determination of Valsartan in tablet dosage forms. J. App Pharm. Sci 1(4):97-99.
Patel NR and Patel SK (2012). First derivative Spectrophotometric method for the simultaneous estimation of Valsartan and Hydrochlorthiazide in their combined dosage form. Int. J. Pharm. And Life sci 3(7): 1828-1832.
Patel KH, Luhar SV, and Narkhede SB (2016). Simultaneous Estimation of Sacubitril and Valsartan in Synthetic Mixture by RP-HPLC Method. J. Pharm. Sci. and Bio. Sci 6(3): 262-269.
The Merk Index, An Encyclopedia of chemical, Drugs and Biological, 14th ed. pp. 9916.
Tripathi K D. (2008). Essential of medical pharmacology, 6th ed. Jaypee Brothers Medical Publishers (p) Ltd, New Delhi.
Vizuda DU, Sailor GU, and Sheth NR (2010). RP-HPLC Method for Determination of Valsartan in Tablet Dosage Form. Int. J. Chem. Tech. Res. 2(3): 1461-1467.