METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF AZELNIDIPINE AND TELMISARTAN IN TABLET DOSAGE FORM BY RP- HPLC

A simple, accurate and precise method for the simultaneous determination of azelnidipine and telmisartan in bulk drug and pharmaceutical dosage has been developed by RPHPLC method. Separation was performed on a Hyperchrom ODS C18 HPLC Column (250*4.6mm) column and Buffer 0.05M Potassium dihydrogen orthophosphate (KH₂PO₄) Buffer (pH-4.0): Methanol (60:40) as a mobile phase, at a flow rate 1ml/min and UV detection wavelength 215 nm. The calibration of the method was performed by concentration range of 20-60μg/ml for telmisartan and 40-120 μg/ml for azelndipine. The validation of proposed method was carried out for accuracy, precision, ruggedness, specificity for both alzenidipine and telmisartan the method can be used for routine quality analysis of titled drug in tablet formulation.

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Analytical Method Development and Validation for Telmisartan, Chlorthalidone and Amlodipine by UV- Spectroscopic Method.

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.01051 ◽

2021 ◽

pp. 6049-6054

Author(s):

Rutuja M. Sanap ◽

Sarika R. Wavhale ◽

Vaibhavi V. Kunjir ◽

Rajkumar V. Shete

Keyword(s):

Simultaneous Determination ◽

Analytical Method ◽

Dosage Form ◽

Method Development ◽

Correction Method ◽

Absorption Correction ◽

Method Development And Validation ◽

Development And Validation ◽

Tablet Dosage

A simple, sensitive and accurate UV- spectrophotometric absorption correction method has been developed for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form. Analytical method development and validation plays important role in the discovery manufacture of pharmaceuticals and development. In this paper, absorption correction method is used for multi-component analysis. The wavelengths selected for the analysis were 311nm for Telmisartan, 228nm for Chlorthalidone and 253nm for Amlodipine. Beer’s law obeyed the concentration range of 2-10 µg /ml, 2-10 µg /ml and 5-25 µg/ ml for Telmisartan, Amlodipine and Chlorthalidone. Methanol is used as a solvent. The accuracy of the method was assessed by recovery studies and was found between the range of 100% to 110% for Telmisartan, 85% to 110% for Amlodipine and 85% to 105% Chlorthalidone. The % RSD value was found to be less than 2. Thus, the method was simple, precise, economic, rapid, accurate and can be successfully applied for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form.

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A Novel UPLC-PDA Stability Indicating Method Development and Validation for the Simultaneous Estimation of Lamivudine and Dolutegravir in Bulk and Its Tablets

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2020/v32i3230933 ◽

2020 ◽

pp. 52-60

Author(s):

Poojari Venkatesh ◽

Umasankar Kulandaivelu ◽

Gsn Koteswara Rao ◽

Guntupalli Chakravarthi ◽

Rajasekhar Reddy Alavala ◽

...

Keyword(s):

Simultaneous Determination ◽

Method Development ◽

Pharmaceutical Formulations ◽

Simultaneous Estimation ◽

Stability Indicating ◽

Stability Indicating Method ◽

Method Development And Validation ◽

Development And Validation ◽

Potassium Dihydrogen Orthophosphate

Aim: To develop a stability indicating Rp-UPLC method for the simultaneous determination of Lamivudine, Dolutegravir and their degradants in tablets. Methodology: The chromatographic separation was performed on BEH Shield RP18 (2.1 mmX100 mmX1.7 mm) using a isocratic mobile phase Potassium dihydrogen orthophosphate pH 3 adjusted with orthophosphoric acid: methanol (30:70,% v/v) at a flow rate of 0.5ml/min. Column was maintained at room temperature and eluents are monitored at 258 nm. Results: Retention times of the analytes were found to be at 0.81 and 2.78 mins for Lamivudine and Dolutegravir respectively. The calibration of peak area versus concentration, which was linear from 105 to 315 µg/ml for Lamivudine and 17.5 to 52.5 µg/ml for Dolutegravir, had regression coefficient (r2) greater than 0.999. The method had the requisite accuracy, precision and robustness for simultaneous determination of Lamivudine and Dolutegravir in tablets. Conclusion: The proposed method is simple, economical, accurate, precise and can be successfully employed in routine quality control for the simultaneous analysis of Lamivudine and Dolutegravir in pharmaceutical formulations.

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