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Experimental Research Paper | Chemistry | Volume 15 Issue 6, June 2026 | Pages: 987 - 991 | India
Development and Validation of Analytical Method for Simultaneous Estimation of Montelukast Sodium and Doxycycline by UV-Visible Spectrophotometry
Abstract: A two simple, accurate, reliable, precise, sensitive and economical spectrophotometric method has been developed for simultaneous estimation of Montelukast Sodium and Doxycycline in pharmaceutical formulations. In the first derivative UV method, methanol was used as a solvent and quantification was achieved at 288 nm for Montelukast sodium and 276 nm for Doxycycline over the concentration range of 5-30 μg/ml for Montelukast Sodium and 5-30 μg/ml for Doxycycline Respectively. The method linearity is observed in the concentration range of 5-30 μg/ml for Montelukast Sodium and 5- 30 μg/ml for Doxycycline. The correlation coefficient of drugs 0.999 for Montelukast Sodium and 0.996 for Doxycycline respectively. The Standard deviation of the Montelukast Sodium was 0.0061and the Doxycycline was 0.0051. The method validated according to ICH guidelines all validation parameter were studied for the proposed method like linearity, precision, LOD, LOQ. The % RSD for recovery study was found to be less than 2% indicating the precision of method. The results were validated statistically as per ICH Q2 R1 guidelines and it was discovered satisfactory. LOD and LOQ for Montelukast Sodium and Doxycycline were discovered to be 0.495μg / ml and 1.539μg / ml. and 0.142 μg/ml and 0.306 μg/ml respectively. Precision, accuracy, and robustness studies confirmed the method's reliability. The validated method is suitable for routine quality control and stability testing of combined Montelukast Sodium and Doxycycline formulations in the pharmaceutical industry. The above two methods were validated by performing analytical parameters which are mentioned under ICH guidelines and all parameters are within acceptable.
Keywords: Montelukast Sodium, Doxycycline, First Derivative UV-Spectroscopy, Deviation, ICH Q2 R1, Validation
How to Cite?: Chabukswar Shital B., Waghmare Sweety M, "Development and Validation of Analytical Method for Simultaneous Estimation of Montelukast Sodium and Doxycycline by UV-Visible Spectrophotometry", Volume 15 Issue 6, June 2026, International Journal of Science and Research (IJSR), Pages: 987-991, https://www.ijsr.net/getabstract.php?paperid=SR26618111626, DOI: https://dx.doi.org/10.21275/SR26618111626