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Department of Pharmaceutical Quality Assurance, K.B.H.S.S. Trust’s Institute of Pharmacy & Research Center, Bhayegaon, Malegaon, Nashik, Maharashtra, India
The purpose of present analytical research was to develop and validate a new, rapid, selective, specific, accurate and efficient stability indicating RP-HPLC-DAD assay test method for the estimation of Desmopressin in Desmopressin tablets. Several liquid chromatographic parameters viz change in mobile phase, buffer solution and solvent composition, analytical column (stationary phase) and column compartment temperature were studied. The elution pattern of Desmopressin are obtained with improved peak shape under a set of gradient chromatographic condition: a reverse phase Inertsil C18 (250mm x4.6mm, 5.0?m) column with a mobile phase A consisting of methanol and mobile phase B is phosphate buffer pH 4.5 (25:75), flow rate 1.2 mL/minute, UV detection wavelength 220 nm. The chromatographic run time was 12 minutes with Desmopressin peak eluting at 6.6 minutes. The developed assay test method was found to be very specific and linear in the range of 5- 15 ?g /mL (r2 = 0.9998). The best precision was obtained because the maximum RSD was 1.25%. Mean recoveries was 100.3%. The percent RSD was less than 2.0%. The test method is robust w.r.t changes in flow rate and wavelength. Solution stability evaluation showed no evidence of degradation product. Standard solution was stable for 88 hours and test sample solution was for 48 hours at room temperature. Forced degradation study (Specificity) of Desmopressin shown that peak was pure and there was no coeluting peaks when samples were assayed against reference solution. The developed analytical test method was validated as per ICH guideline and found precise, robust, accurate, linear, specific and stability indicating ensuring suitability of the test method for estimation of Desmopressin in tablets. Assay test method was successfully used for routine analysis of Desmopressin formulations and Oral solid dosage forms.
Rashid Azeez*, Vinod A. Bairagi, Ziyaurrahman Azeez, A Novel Validated Stability Indicating Qbd Based Assay Method For The Quantification Of Desmopressin Acetate By High Performance Liquid Chromatography, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 12, 166-178. https://doi.org/10.5281/zenodo.10316417
10.5281/zenodo.10316417