& A new high performance liquid chromatography method was developed and validated for the quantitation of tramadol, paracetamol, and domperidone in pharmaceutical formulations. Determination was performed using a Inertsil-ODS-3 (C -18 ) column (5 lm, 250 mm  4.60 mm), a mobile phase containing methanol-phosphate buffer (pH 4.0; 40 þ 60, v=v), in gradient flow rate 1.2 mL. The method was validated with respect to linearity, precision, robustness, and accuracy. The calibration graphs ranged from 250 to 1500 mg=mL for paracetamol, 25 to 150 mg=mL for tramadol, and 5 to 30 mg=mL for domperidone. Intra-and interday relative standard deviation values for the standard solutions were 0.077%, 0.98 %, and 1.04 %, respectively. Repeatability of relative standard deviation values was 0.115 %, 0.494 %, and 1.97 % respectively. Total recoveries of paracetamol, tramadol, and domperidone from the laboratory prepared mixtures were 100.4, 100.06, and 100.2 %, respectively.
Background
Cilnidipine (CLD) and valsartan (VAL) are antihypertensive agents used in the treatment of hypertension. So, pharmacokinetic study of CLD and VAL in rat plasma was carried out using chromatographic method. The chromatographic separation was performed on the Inertsil ODS column, using mobile phase methanol: water 85:15 v/v (pH 3.0) at the flow rate of 1.1 mL/min., detected at 254 nm.
Result
Cilnidipine (CLD) (1 mg/kg) and valsartan (VAL) (1 mg/kg) was administered orally in rats, and blood samples were collected at time intervals of 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 h after dosing. The retention time of plasma, CLD, and VAL was found to be 2.7, 6.6, and 4.3 min, respectively. The result was validated statistically and by recovery studies. Linearity was acceptable in the range of 1–5 and 8–40 μg/mL for CLD and VAL, respectively. Maximal concentration (Cmax) of CLD and VAL was observed to be 338 ± 13.85 and 1282.21 ± 39.23 (ng/mL). The half-life of CLD and VAL was found to be 1.08 ± 0.21 and 1.43 ± 0.12 h, respectively.
Conclusion
The present method was successfully applied to the pharmacokinetic study of cilnidipine (CLD) and valsartan (VAL) in rat plasma after oral administration.
A new high performance liquid chromatography method was developed and validated for the quantitation of Cilnidipine and Valsartan in pharmaceutical formulations. Determination was performed using an ODS C18, 250mm x 4.6mm, 5μm column, a mobile phase containing Methanol: Water (85:15) pH 3 adjusts with ortho-phosphoric acid in isocratic flow rate 1.0 mLmin-1. The method was validated with respect to linearity, precision, robustness, and accuracy. The calibration graphs ranged from 1-5 μg/mL in Cilnidipine and 8-40 μg/mL Valsartan Intra-and interday relative standard deviation values for the standard solutions were 0.5%, 1.64% and 0.22%, 1.62 %. Robustness of relative standard deviation values was 0.334, 0.101 respectively. Total recoveries of Cilnidipine and Valsartan from the laboratory prepared mixtures were 98.94 % and 99.04 % respectively.
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