Abstract: The present invention discloses novel spectrophotometric methods for the precise quantification of Rosuvastatin (ROS) in pharmaceutical bulk compounds and solid dosage forms. These methods utilize three distinct solvent systems: methanol (Method I, ?max=236 nm), 2-propanol (Method II, ?max=230 nm), and concentrated H2SO4 (Method III, ?max=415 nm). Each method exhibits a linear calibration range, with Method I and II spanning 1-6 µg/ml and Method III covering 10-60 µg/ml. Furthermore, the Beer's law ranges extend from 1-15 µg/ml, 1-15 µg/ml, and 10-250 µg/ml for Method I, II, and III, respectively. Notably, the mean recovery values for ROS were found to be 97.5%, 97.5%, and 103.5% for Methods I, II, and III, respectively. The precision and accuracy of the developed methods were rigorously assessed through validation procedures in accordance with the International Conference on Harmonization (ICH) guidelines. These findings underscore the potential utility of the proposed spectrophotometric approach for the routine determination of ROS in pharmaceutical formulations.
Description:Method I: Methanol
To prepare a sample solution for Method I, 20 tablets are accurately weighed and finely powdered. An amount corresponding to 100 mg of Rosuvastatin is measured and transferred to a 100 ml volumetric flask. To this, 50 ml of methanol is added, and the mixture is vigorously agitated until complete dissolution of the drug is achieved. Subsequently, the solution undergoes filtration and is brought to a final volume of 100 ml with methanol. This resulting solution is appropriately diluted to attain the desired concentration.
Aliquots of the working standard solution of Rosuvastatin ranging from 1 to 6 ml (100 µg/ml) are meticulously transferred into a series of 10 ml volumetric flasks. The volumetric flasks are meticulously adjusted to the mark with methanol. Subsequently, the absorbance of the prepared samples is meticulously measured spectrophotometrically at 236 nm against a reagent blank.
Method II: 2-propanol
To prepare a sample solution for Method II, the same procedure as Method I is followed, except that 2-propanol is used as the solvent. The absorbance of the prepared samples is meticulously measured spectrophotometrically at 240 nm against a reagent blank.
Method III: Concentrated H2SO4
To prepare a sample solution for Method III, the same procedure as Method I is followed, except that concentrated H2SO4 is used as the solvent. The absorbance of the prepared samples is meticulously measured spectrophotometrically at 415 nm against a reagent blank.
, Claims:1. A spectrophotometric method for the quantification of Rosuvastatin (ROS) in pharmaceutical formulations, comprising:
a) Preparing a sample solution by dissolving ROS in a solvent selected from the group consisting of methanol, 2-propanol, and concentrated H2SO4;
b) Measuring the absorbance of the sample solution spectrophotometrically at a wavelength selected from the group consisting of 236 nm, 240 nm, and 415 nm; and
c) Quantifying the amount of ROS in the sample solution based on the absorbance measurement.
2. The method of claim 1, wherein the solvent is methanol and the wavelength is 236 nm.
3. The method of claim 1, wherein the solvent is 2-propanol and the wavelength is 240 nm.
| # | Name | Date |
|---|---|---|
| 1 | 202341081661-REQUEST FOR EXAMINATION (FORM-18) [01-12-2023(online)].pdf | 2023-12-01 |
| 2 | 202341081661-REQUEST FOR EARLY PUBLICATION(FORM-9) [01-12-2023(online)].pdf | 2023-12-01 |
| 3 | 202341081661-FORM 1 [01-12-2023(online)].pdf | 2023-12-01 |
| 4 | 202341081661-COMPLETE SPECIFICATION [01-12-2023(online)].pdf | 2023-12-01 |
| 5 | 202341081661-FER.pdf | 2025-06-20 |
| 1 | 202341081661_SearchStrategyNew_E_SearchHistory202341081661E_18-06-2025.pdf |