ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DILTIAZEM HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP- HPLC

  • Bhagyashree R. Patil
  • O. G. Bhusnure
  • B. N. Paul
  • A. Y. Ghodke
  • Suraj S. Mulaje

Abstract

A simple, specific, precise and accurate Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the estimation of Diltiazem Hydrochloride in bulk and pharmaceutical dosage form. The chromatographic determination was performed on isocratic high performance liquid chromatography system of Agilent model no.1220. The separation was conducted by using column of Zorbax [C8 (5µ, 4.6 mm×250)] with mobile phase consisting of buffer and Acetonitrile in the ratio of (60:40). The mobile phase was delivered at the flow rate of 1.0ml/min. The eluent was monitored at wavelength 240 nm and found a sharp and symmetrical peak with retention time of 4.66min. The method was validated for linearity, accuracy, precision, specificity, robustness. Recovery of Diltiazem Hydrochloride was found to be in the range of 98%-102%. The method was found to be linear over the concentration range 50-150 µg/ml with coefficient correlation r2 = 0.995. After developing method, validation parameters were carried out successfully and obtained results were complied with USP monograph.

Keywords: Diltiazem Hydrochloride; Precision; Accuracy; Method Validation; Reverse phase chromatography.

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References

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Patil, B. R., O. G. Bhusnure, B. N. Paul, A. Y. Ghodke, and S. S. Mulaje. “ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DILTIAZEM HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP- HPLC”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 2, Feb. 2018, pp. 78-84, doi:10.22270/ijdra.v2i2.133.