Sensitive High Performance Thin Layer Chromatographic Determination of Lercanidipine Hydrochloride in Pharmaceuticals and in Blood Plasma
 
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Department of Quality Assurance Techniques, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, India
CORRESPONDING AUTHOR
Sagar Baliram Wankhede   

Department of Quality Assurance Techniques, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, India
Publish date: 2017-10-26
 
Eurasian J Anal Chem 2016;11(3):141–154
KEYWORDS
ABSTRACT
A HPTLC method was developed and validated for determination of Lercanidipine hydrochloride in tablet formulation and in biological sample. The chromatography was performed on pre-coated silica gel 60 F254 plates using methanol-toluene 2.5:7.5 (v/v) as mobile phase. The optimized chromatographic conditions gave good peak shape with acceptable Rf value of 0.70 for Lercanidipine. Method was validated according to the ICH guidelines. The calibration plots were linear between 100-600 ng/ band and between 50-500 ng/ band in pure and in biological sample, respectively. Accuracy of the proposed method was evaluated by recovery studies (% recovery= 100.22 % and 99.99 % from tablet sample and biological sample, respectively). The method was also validated for precision, ruggedness, LOD & LOQ and robustness as per ICH guidelines. In stability testing, Lercanidipine was found susceptible to acid hydrolysis, alkali hydrolysis and oxidation (3 % H2O2). The method was able to selectively quantitate Lercanidipine hydrochloride in presence of degradation products and components likely to be present in biological matrix.
 
REFERENCES (13)
1.
Nilesh J, Ruchi J, Navneet T, Surendra J, Deepak K J (2013) Simultaneous spectrophotometric estimation of Lercanidipine hydrochloride and Atenolol in tablet dosage form. Eurasian Journal of Analytical Chemistry 6(2), 84-90.
 
2.
Mubeen G, Damanjit S R, Kadri U (2009) Spectrometric method for determination of Lercanidipine in tablets. International Journal of Chem. Tech. Research 1(4), 1186-1188.
 
3.
Ramesh J, Radhakrishnan M (2013) Development and validation of RP-HPLC method for the dissolution of Lercanidipine hydrochloride in tablet dosage form. International Journal of Research in Pharmaceutical and Biomedical Sciences 4(3), 1014-1023.
 
4.
Priyadarshani S B, Mahendra S R, Kamble R, Chetan S C. (2014) Development and validation of Lercanidipine hydrochloride and Atenolol by using RP-HPLC and UV spectroscopy. Indian journal of pharmacy and pharmacology 1(1), 37-41.
 
5.
Ramesh J, Radhakrishnan M (2013) Development and validation of RP-HPLC method for the estimation of Lercanidipine hydrochloride in tablet dosage form. International Journal of Research in Pharmaceutical and Biomedical Sciences 4(4), 1197-1207.
 
6.
Ramesh J, Radhakrishnan M. (2013) Development and validation of RP-HPLC method for the chromatographic purity of Lercanidipine hydrochloride in tablet dosage form. International Journal of Pharmacy and Pharmaceutical Sciences 5(4), 255-263.
 
7.
Saumil M, Sukhdev S, Kishor C (2014) A fast, stability-indicating, and validated liquid chromatography method for the purity control of Lercanidipine hydrochloride in tablet dosage form. Scientia Pharmaceutica 82, 327-340.
 
8.
Mahaboob S S, Bala S R, Sarbudeen M (2014) Analytical Method Development and Validation for Simultaneous estimation of Lercanidipine and Atenolol Tablet Dosage Form by RP-HPLC. International Journal of Pharmacy and Analytical Research 3(1), 147-156.
 
9.
Kareem M Y, Ehab F K (2013) A new validated bio-analytical liquid chromatographic tandem mass spectrometric method for the quantification of Lercanidipine in human plasma. International Journal of Analytical and Bioanalytical Chemistry 3(4), 169-177.
 
10.
Madgalene K, Stavroula M, Nikoleta R, Maria K, Irene P (2006) Ultra-performance liquid chromatography / tandem mass spectrometry method for the determination of Lercanidipine in human plasma. Rapid communications in mass spectrometry 20, 2939-2946.
 
11.
Guidelines Prepared within the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human use (ICH) 2005.
 
12.
Validation of analytical Procedure, Text and Methodology Q2 (R1): 1-13.
 
13.
Guidance for Industry Bioanalytical Method validation prepared by the Biopharmaceutics coordinating committee in the centre for drug evaluation and research (CDER) in cooperation with the Centre for Veterinary medicine (CVM) at Food and Drug Administration 2001, 2- 25.
 
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