Comparative analysis of analytical method development and its validation for the simultaneous estimation of Bilastine and Montelukast Sodium in bulk and its tablet formulation by planar chromatography

Seema Gosavi; Aditi Kulkarni; Sarita Pawar; Suchita Dhamane; Prasad Gorde; Girija Bhavar; Kajal Shirapure

doi:10.52756/ijerr.2023.v32.034

Authors

Seema Gosavi Department of Pharmaceutical Chemistry, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India https://orcid.org/0000-0003-3724-3324
Aditi Kulkarni Department of Pharmacognosy, Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk), Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India https://orcid.org/0000-0003-4200-1987
Sarita Pawar Department of Pharmaceutical Chemistry, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India https://orcid.org/0000-0001-5264-157X
Suchita Dhamane Department of Pharmaceutics, JSPM's Jayawntrao Sawant College of Pharmacy & Research, Hadapsar, Savitribai Phule Pune University, Pune, Maharashtra, India https://orcid.org/0000-0002-5330-170X
Prasad Gorde Department of Pharmaceutical Chemistry, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India https://orcid.org/0000-0001-6356-7918
Girija Bhavar Department of Pharmaceutical Chemistry, Shri Vile Parle Kelavani Mandal's Institute of Pharmacy, Dhule, Dr. Babasaheb Ambedkar Technological University, Lonere, Raigad, Maharashtra, India https://orcid.org/0000-0001-5931-4109
Kajal Shirapure Department of Quality Assurance Techniques, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India https://orcid.org/0009-0002-0874-8251

DOI:

https://doi.org/10.52756/ijerr.2023.v32.034

Keywords:

Ertugliflozin, RP-HPLC, Sitagliptin, Tablet

Abstract

The development and validation of analytical methods are crucial in guaranteeing the precision, dependability, and excellence of pharmaceutical analysis. This research investigates the field of pharmaceutical chemistry by doing a comparative examination of analytical techniques for the simultaneous determination of Bilastine and Montelukast Sodium in both bulk and tablet forms. The selected method for this analysis is planar chromatography. The simplicity, specificity, precision, and accuracy of a high-performance liquid chromatography (HPTLC) approach were investigated for their use in the simultaneous estimation of the antihistaminic combination medication Bilastine and Montelukast Sodium in bulk and its pharmaceutical dose for the treatment of allergic rhinitis. Densitometric readings were taken at 254 nm after separating substances using ethyl acetate, toluene, methanol, and ammonia (7:0.5:1.5:0.5v/v/v/v) as mobile phase and precoated aluminium silica gel plates (60F254) as stationary phase. Bilastine and montelukast Sodium have Rf values 0.2 (Bilastine) & 0.4 (Montelukast Sodium), which is considered an acceptable resolution. The International Conference on Harmonization's (ICH) requirements validated the processes for accuracy, linearity, precision, robustness, and system adaptability. Bilastine and Montelukast Sodium concentrations were determined without any disruption from the excipients. Both Bilastine and Montelukast Sodium were effectively quantified using the suggested method, which bodes well for its utility in enhancing quality assurance.

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