Stability Indicating RP-HPLC Method For Simultaneous Estimation of Ranolazine and Atenolol

This study aimed to develop stability indicating RP-HPLC method for simultaneous estimation of Ranolazine and Atenolol in bulk and formulation. This work established and validated a reliable, accurate, and precise RP-HPLC technique for Ranolazine and Atenolol estimation. The stationary phase was Shimadzu C18 (Phenomenex Gemini NX 100×4.6µm, 5µm). Successful separation was achieved using liquid chromatography with a mobile phase comprising of 1 phosphate buffer (0.05 M) and methanol with gradient method. The flow rate was established at 1.50 ml/min. Estimation has been done at ambient temperature with gradient elution in an RP-HPLC chromatograph at λ max 240 nm. Validation was conducted in accordance with ICH Q2 R1 guidelines. The new method demonstrates a strong connection between peak area and drug concentration under prescribed conditions, with recoveries ranging from 99.8% to 103.1% for Ranolazine and 98.6% to 102.4% for Atenolol. This suggests that routinely used excipients in pharmaceutical formulation did not interfere with the suggested technique. Differences of less than 2.0% for intra- and inter-day data demonstrate the method's precision. The presence of % RSD less than 2.0 for both intra- and inter-day measurements suggests a high level of precision. The proportion of degradation for RAN and ATN ranged from 5.306% to 11.154%. The proposed approach is dependable, accurate, and exact for assessing both Ranolazine and Atenolol at the same time. Thus, this method can be used to quantify low quantities of Ranolazine and Atenolol in bulk and pharmaceutical dosage forms.