Dr. Bhaveshkumar Patel
- Associate Professor, K.B. Institute of Pharmaceutical Education and Research, Gujarat, India
Abstract
There are several medicinal agents are available for antihypertensive activity. Telmisartan, Metoprolol and Cilnidipine are among them. Quantitative and qualitative analysis play a pivot role to safeguard patients. Here, estimation of these drugs was performed by using chromatographic technique RP-HPLC. It was conducted with Phosphate buffer (pH 3.5 ± 0.01): Methanol (50:50 v/v) mobile phase. The system was operated at 1ml/min. Drug volume to system was 20µl. The column as a stationary Phase was C18, Hypersil BDS with 250mm*4.6mm dimension. In experimental section, linearity and range was kept between 20 to 60 µg/ml for Telmisartan, 5 to 15 µg/ml for Cilnidipine and 25 to 75 µg/ml for Metoprolol. The drugs were eluted at 3.4, 4.1 and 11.5 min. for Telmisartan, Metoprolol and Cilnidipine, respectively. Accuracy study was found to be 98.32 to 101.57 % for all three drugs. % RSD value of repeatability study was less than 2 %. The determination of drugs were carried out at 215 nm. The method was also applied to pharmaceutical dosage form. The proposed study was validated by ICH guideline. The proposed study also extended for degradation protocol for all the drugs. The drugs were exposed to various conditions include acidic, basic, oxidation and thermal and photolytic. The force degradation had shown more degradation in oxidative condition, 35.98 % for Telmisartan while 29.07 % and 36.67 % in basic condition for Metoprolol succinate and Cilnidipine, respectively. Very least degradation had been observed in photolytic condition. It was 13.11 %, 14.39 % and 15.25% for Telmisartan, Metoprolol and Cilnidipine, respectively. The validated procedure would have application regarding stability indicating, impurity separation, qualitative and quantitative estimation of Telmisartan, Metoprolol and Cilnidipine in solid dosage form.
Keywords: Telmisartan, Metoprolol, Cilnidipine, HPLC, Validation, Degradation.
[This article belongs to Research & Reviews: A Journal of Drug Design & Discovery(rrjoddd)]
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References
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Research & Reviews: A Journal of Drug Design & Discovery
| Volume | 11 |
| Issue | 01 |
| Received | April 1, 2024 |
| Accepted | April 5, 2024 |
| Published | April 15, 2024 |