RESUMEN
Objective: A simple, sensitive and rapid LC-MS/MS technique was developed for the quantitation of trandolapril (TDL) and verapamil (VPL) in a biological matrix and validated. Methods: Sample preparation processed by SPE (Solid Phase extraction) on phenomenex cartridge using Ledipasvir as an internal standard. Two drugs were eluted on waters symmetry-RP18 (5µ, 150 mm×4.0 mm) column with the mobile composition of 10 mmol ammonium formate and ACN(acetonitrile) in the ratio of 70:30 %V/V. Detection and quantitation were processed by electrospray ionization in positive ionization mode. Results: The quantification approach was validated in 5-1500 ng/ml linear concentration range for TDL and 1-2000 ng/ml for VPL. The intraday and inter-day precision and accuracy were found to be 0.58% to 5.69% and 93% to 104% for two drugs. The average recoveries for TDL and VPL were found to be 92.9% and 93.5% respectively. Conclusion: The developed work was validated and can be applicable to the routine analysis of TDL and VPL simultaneously in a biological matrix.
RESUMEN
Trandolapril is an antihypertensive agent which undergoes extensive first pass metabolism making it a possible candidate for transdermal delivery. Patches were prepared using hydroxypropylmethylcellulose, eudragit RL 100, gantrez and carbopol. The results of FTIR and DSC revealed no interaction between drug and polymers. The loss of moisture and uptake of moisture were within the limits. The formulations showed an extended release of the drug upto period of 24 hours during in vitro permeation studies and showed non-Fickian drug release. Stability of the optimized formulation was investigated as per ICH guidelines and was found to be stable with respect to drug content and in vitro permeation.
RESUMEN
Objective: To compare the efficacy and tolerability between trandolapril and enalapril in mild-to-moderate hypertension. Material and Methods: This was a prospective, double-blind, parallel, comparative clinical trial involving 120 patients with mild-to-moderate hypertension. Patients were randomized to receive trandolapril 2-4 mg once-daily and enalapril 5-10 mg once-daily. The participants were followed for eight weeks. Results: Both the drugs achieved effective control of blood pressure (BP) at the end of eight weeks. The mean reduction in systolic BP (SBP) was 22.17 mmHg with trandolapril and 21.47 mmHg with enalapril group; the mean reduction of diastolic BP (DBP) was 9.57 mmHg with trandolapril and 11.13 mmHg with enalapril. Adverse events developed in 11 (18.3%) and 12 (20%) patients in trandolapril and enalapril group, respectively. Conclusion: The efficacy and tolerability of trandolapril was comparable to enalapril in mild-to-moderate hypertension with minor adverse events.