Zero crossing and ratio spectra derivative spectrophotometry for the dissolution tests of amlodipine and perindopril in their fixed dose formulations

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Abstract

Dissolution tests of amlodipine and perindopril from their fixed dose formulations were performed in 900 mL of phosphate buffer of pH 5.5 at 37°C using the paddle apparatus. Then, two simple and rapid derivative spectrophotometric methods were used for the quantitative measurements of amlodipine and perindopril. The first method was zero crossing first derivative spectrophotometry in which measuring of amplitudes at 253 nm for amlodipine and 229 nm for perindopril were used. The second method was ratio derivative spectrophotometry in which spectra of amlodipine over the linearity range were divided by one selected standard spectrum of perindopril and then amplitudes at 242 nm were measured. Similarly, spectra of perindopril were divided by one selected standard spectrum of amlodipine and then amplitudes at 298 nm were measured. Both of the methods were validated to meet official requirements and were demonstrated to be selective, precise and accurate. Since there is no official monograph for these drugs in binary formulations, the dissolution tests and quantification procedure presented here can be used as a quality control test for amlodipine and perindopril in respective dosage forms.

References

  • 1. Bhaskara Raju V., Lakshmana Rao A.: Simultaneous estimation of perindopril and amlodipine in combined dosage form by RP-HPLC method. Int. J. Chem. Sci., 9, 1290, 2011.

  • 2. Graffner C.: Regulatory aspects of drug dissolution from a European perspective, Eur. J. Pharm. Sci., 29, 288, 2006.

  • 3. Gumieniczek A. et al.: New HPLC method for in vitro dissolution study of antihypertensive mixture amlodipine and perindopril using an experimental design, Cent. Eur. J. Chem., 11, 717, 2013.

  • 4. Hajian R., Afshari N.: The spectrophotometric multicomponent analysis of a ternary mixture of ibuprofen, caffeine and paracetamol by the combination of double divisor-ratio spectra derivative and H-point standard addition method. E-J. Chem., 9, 1153, 2012.

  • 5. Nayak S.P., Pillai S.: Simultaneous estimation of amlodipine besylate and perindopril erbumine by UV spectrophotometric method. Res. J. Pharm. Technol., 4, 735, 2011.

  • 6. Pattan S.R. et al.: Analytical method development and validation of perindopril erbumine and amlodipine besylate in bulk and tablet dosage form by HPLC. Indian Drugs, 50, 32, 2013.

  • 7. Prajapati J. et al.: Analytical method development and validation of amlodipine besylate and perindopril erbumine in combine dosage form by RP-HPLC. Int. J. PharmTech. Res., 3, 801, 2011.

  • 8. Ram C.V.S. et al.: Comparative effectiveness analysis of amlodipine/ renin angiotensin system blocker combinations. J. Clin. Hypertens., 14, 601, 2012.

  • 9. Rojas F.S., Ojeda C.B.: Recent development in derivative ultraviolet/ visible absorption spectrophotometry: 2004-2008 A review, Anal. Chim. Acta, 635, 22, 2009.

  • 10. Walash M.I., Rizk M.S., Sheribah Z.A., Sheribah Z.A., Salim M.M.: Derivative spectrophotometric analysis of benzophenone (as an impurity) in phenytoin, Chem. Cent. J., 5, 85, 2011.

  • 11. Youssef R.M., Maher H.M.: A new hybrid double divisor ratio spectra method for the analysis of ternary mixtures, Spectrochim. Acta Part A, 70, 1152, 2008.

  • 12. Zaazaa H. E., Abbas S.S, Essam H.A.M., El-Bardicy M.G.: Validated chromatographic methods for determination of perindopril and amlodipine in pharmaceutical formulation in the presence of their degradation products, J. Chromatogr. Sci., 51, 533, 2013.

Current Issues in Pharmacy and Medical Sciences

Formerly Annales UMCS Sectio DDD Pharmacia

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CiteScore 2016: 0.19

SCImago Journal Rank (SJR) 2016: 0.132
Source Normalized Impact per Paper (SNIP) 2016: 0.119

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