Chromatographic Development and Validation of High-performance Thin Layer Chromatography Method for Concurrent Estimation of Azelnidipine and S (-) Metoprolol Succinate in Bulk and Tablets

Title:Chromatographic Development and Validation of High-performance Thin Layer Chromatography Method for Concurrent Estimation of Azelnidipine and S (-) Metoprolol Succinate in Bulk and Tablets

Volume: 3

Author(s): Saylee Ganorkar, Aditya Bhavsar, Pramod Sakpal and Rahul Khiste*

Affiliation:

• Department of Pharmaceutical Chemistry and Pharmaceutical Quality Assurance, Marathwada Mitra Mandal’s College of Pharmacy, Thergaon, Pune, Maharashtra, India

Keywords: Azelnidipine, S (-) metoprolol succinate, HPTLC, validation, force degradation study, linearity.

Abstract:

Background: Azelnidipine a calcium channel blocker belongs to BCS class II and S (-) Metoprolol Succinate belongs to BCS class I. The ever-increasing number of drugs and their combinations in the market leads to the need for the development of analytical methods for their quality control.

Objective: For the concurrent detection of Azelnidipine (AZEL) and S (-) Metoprolol Succinate (MTS) in bulk and pharmaceutical combination dosage form, a simple, selective, and accurate high-performance thin layer chromatographic technique was developed and validated. To determine the stability of formulation in various conditions force degradation study was carried out as per ICH Q1 guidelines.

Method: The stationary phase for the method was silica gel 60F 254 (10X10) precoated aluminium plates for HPTLC. Toluene: Ethyl acetate: Methanol: Glacial acetic acid were the solvents of the solvent system (6:2:2:0.1 v/v/v/v).

Result: A compact spot for both azelnidipine and metoprolol succinate was detected in the system (Rf = 0.66 and 0.22, respectively). Utilizing the absorbance mode at 236 nm, densitometric measurement of Azelnidipine and S (-) Metoprolol Succinate was performed. Linear regression analysis results for the calibration plots showed good linear relationships with R² values of 0.9997 and 0.9992 for peak areas in the concentration range 200-1000 ng per spot for Azelnidipine and with respect to peak areas in the concentration range 200-1000 ng per spot for S (-) Metoprolol Succinate. Precision, recovery, and robustness of the method were validated as per ICH guidelines. In alkaline condition, major degradation of S (-) Metoprolol succinate was observed. Azelnidipine showed major degradation in acidic condition.

Conclusion: A statistical study demonstrated that the method is accurate, precise, and selective for the estimation of metoprolol and azelnidipine. From the results of forced degradation studies, it is concluded that formulation has sufficient stability in various stress conditions.

Cite this article as:

Ganorkar Saylee, Bhavsar Aditya, Sakpal Pramod and Khiste Rahul*, Chromatographic Development and Validation of High-performance Thin Layer Chromatography Method for Concurrent Estimation of Azelnidipine and S (-) Metoprolol Succinate in Bulk and Tablets, Current Chinese Chemistry 2023; 3 : e150923221186 . https://dx.doi.org/10.2174/2666001603666230915161005