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Stability Indicating Derivative Spectrophotometric Methods for Determination of Trandolapril in Bulk and in Formulation
Abstract
Trandolapril is an oral angiotensin-converting enzyme (ACE) inhibitor approved by the USFDA for the therapy of hypertension and congestive heart failure. This paper describes the validation of zero- and firstorder derivative UV spectrophotometric methods for the estimation of trandolapril in bulk and in its marketed tablet formulation. Preliminary spectrophotometric determination of the drug was carried out in phosphate buffer pH 2.0 or 0.1 N HCl. A total of 17 parametric method variants were investigated out of which three variants employing peak–zero (P–0) and peak–peak (P–P) techniques were validated with respect to linearity, accuracy, precision, and robustness. The developed methods were also assessed for stability indicating potential in force degraded solutions. Linearity was observed in the concentration range of 1.0–70.0 μg/mL with an excellent correlation coefficient (r2) ranging from 0.9981–0.9998. The limits of assay detection values were found for the range of 0.88–1.23 μg/mL, and quantitation limits ranged from 2.66–6.09 μg/mL for the proposed methods. The proposed methods were extended to the quantification of the drug in its marketed tablet formulation with good recoveries (90–98%).
Supporting agencies: We sincerely thank Lupin Pharmaceuticals Pvt. Ltd., Goa (India) for graciously providing us with pure samples of trandolapril. The research grant provided by the University Grants Commission is duly acknowledged. This work was supported by the University Grants Commission (UGC), New Delhi, India (Grant No. 36/N/296)
About the Authors
V. K. Jaiswal
University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University
India
India
Vinod Kumar Jaiswal
Chandigarh
A. Bali
University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University
India
India
Alka Bali
Chandigarh
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Review
For citations:
Jaiswal V.K., Bali A. Stability Indicating Derivative Spectrophotometric Methods for Determination of Trandolapril in Bulk and in Formulation. Zhurnal Prikladnoii Spektroskopii. 2023;90(6):971.
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