New Stability Indicating Method for Quantification of Impurities in Amlodipine and Benazepril Capsules by Validated HPLC

Rama Joga Venkata Eranki, Gopichand Inti, Venkatasubramanian Jayaraman, Raghuram Pannala, Sudhakar Rao Vidiyala, Jadi Sree Ramulu

Department of Chemistry, Sri Krishnadevaraya University, Anantapur, India.
Quality & Analytical Development Department, InvaGen Pharmaceuticals, Inc., Hauppauge, USA.
Quality & Analytical Development Department, InvaGen Pharmaceuticals, Inc., Hauppauge, USA Department of Chemistry, Sri Krishnadevaraya University, Anantapur, India.
Quality Assurance Department, ScieGen Pharmaceuticals, Inc., Hauppauge, USA.

DOI: 10.4236/ajac.2013.412086                

Abstract

A stability indicating LC method was developed for the simultaneous determination of Amlodipine and Benazepril capsules in pharmaceutical dosage form. Efficient chromatographic separation was achieved on Symmetry C₁₈ stationary phase with simple combination of amobile phase containing 750 mL of DI Water, 250 mL of Acetonitrile and 2 mL of Octylamine into suitable container with adjusted pH to 2.50 ± 0.05 with the aid of Ortho phosphoric acid delivered in an isocratic mode and quantification was carried out using UV detection at 240 nm at a flow rate of 1.0 mL·min^-1 with an injection volume of 20 μl and ambient column temperature. This method is capable to detect both the drug components of Amlodipine and Benazepril in presence of their degradation products (Amlodipine Imp-A and Benazepril Impurity-C) with a detection level of 0.05%. Amlodipine/Benazepril in their combination drug product were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the samples were analysed. Peak homogeneity data of Amlodipine and Benazeprilis were obtained using PDA detector, in the stressed sample chromatograms, demonstrating the specificity. The method shows excellent linearity over a range of 0.05%-2.0% for Amlodipine, Amlodipine Impurity-A and 0.05%-5.0% for Benazepril and Benazepril Impurity-C. The correlation coefficient for Amlodipine and Benazepril is 1. The relative standard deviation was always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of Amlodipine and Benazepril in pharmaceutical preparations. The developed HPLC method was validated with respect to linearity & range, accuracy, precision and robustness.

Keywords

Column Liquid Chromatography; Method Validation; Stability Indicating Study Amlodipine and Benazepril

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	S. Budavari, “The Merck Index,” 14th Edition, Merck and Co. Press, Whitehouse Station, 2006.
[2]	http://lotrel.org/
[3]	The United States Pharmacopoeia Convention, Inc., Rockville, 2007, pp. 2466-2467.
[4]	The United States Pharmacopoeia Convention, Inc., Rockville, 2007, pp. 2608-2610.
[5]	A. Zarghi, S. M. Foroutan, A. Shafaati and A. Khoddam, “Validated HPLC Method for Determination of AML in Human Plasma and Its Application to Pharmacokinetic Studies,” Farmaco, Vol. 60, No. 9, 2005, pp. 789-792. http://dx.doi.org/10.1016/j.farmac.2005.06.012
[6]	G. Bahrami and S. H. Mirzaeei, “Simple and Rapid HPLC Method for Determination of AML in Human Serum with Fluorescence Detection and Its Use in Pharmacokinetic Studies,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 36, No. 1, 2004, pp. 163-168. http://dx.doi.org/10.1016/j.jpba.2004.05.016
[7]	B. G. Chaudhari and N. M. Patel, “Development and Validation of HPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Amlodipine Besylate,” Journal of Pharmacy Research, Vol. 5, 2006, pp. 141-144.
[8]	A. P. Agrekar and S. G. Powar, “Reverse Phase High Performance Liquid Chromatographic Determination of Ramipril and AML in Tablets,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 21, 2000, pp. 1137-1142.
[9]	B. G. Chaudhari, N. M. Patel and P. B. Shah, “Stability Indicating RP-HPLC for Simultaneous Determination of Atorvastatin Calcium and AML Besylate from Their Combination Drug Products,” Chemical and Pharmaceutical Bulletin, Vol. 55, No. 2, 2007, pp. 241-246. http://dx.doi.org/10.1248/cpb.55.241
[10]	K. K. Pandya, M. Satia, T. P. Gandhi, I. A. Modi, R. I. Modi and B. K. Chakravarthy, “Detection and Determination of Total AML by High Performance Thin Layer Chromatography,” Journal of Chromatography B: Biomedical Sciences and Applications, Vol. 667, No. 2, 1995, pp. 315-320. http://dx.doi.org/10.1016/0378-4347(95)00016-C
[11]	S. N. Meyyanthan and B. Suresh, “HPTLC Method for the Simultaneous Determination of AML and Benazepril in Their Formulations,” Journal of Chromatographic Science, Vol. 43, No. 2, 2005, pp. 73-75. http://dx.doi.org/10.1093/chromsci/43.2.73
[12]	Y. Feng, L. Zhang, Z. Shen, F. Pan and Z. Zhang, “Analysis of AML in Human Plasma by Liquid Chromatography-Mass Spectrometry,” Journal of Chromatographic Science, Vol. 40, 2002, pp. 49-53.
[13]	J. Bhatt, S. Singh, G. Subbaiah, B. Shah, S. Kambli and S. Ameta, “A Rapid and Sensitive Liquid Chromatography Tandem Mass Spectrometry (LCMS/MS) for the Estimation of AML in Human Plasma,” Biomedical Chromatography, Vol. 21, No. 2, 2007, pp. 169-175. http://dx.doi.org/10.1002/bmc.730
[14]	M. D. Malesuik, S. G. Cardoso, L. Bajerski and F. A. Lanzanova, “Determination of AML in Pharmaceutical Dosage Forms by Liquid Chromatography and Ultraviolet Spectrophotometry,” Journal of AOAC International, Vol. 89, 2006, pp. 359-364.
[15]	R. Sahu and V. B. Patel, “Simultaneous Spectrophotometric Determination of AML Besylate and Atorvastatin Calcium in Binary Mixture,” Indian Journal of Pharmaceutical Sciences, Vol. 69, No. 1, 2007, pp. 110-111. http://dx.doi.org/10.4103/0250-474X.32119
[16]	V. E. Rama Joga, I. Gopichand, J. S. Venkat, V. Sudhakar and J. Sree Ramulu, “New Stability Indicating Method for Quantification of Impurities in Amlodipine and Valsartan Tablets by Validated HPLC,” ISRN Medicinal Chemistry, 2013.