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Method development and validation for simultaneous determination of Eletriptan hydrobromide and Itopride hydrochloride from fast dissolving buccal films by using RP-HPLC

Siddique Waqar, Sarfraz Rai Muhammad, Zaman Muhammad, Khan Riffat, Gul Maria, Asghar Farhan, Malik Tangina, Saif Asiya, Shamim Qurat-Ul-Ain, Salawi Ahmad, Alshamrani Meshal, Almoshari Yosif, Sabei Fahad Y.

Acta Chromatographica

2023

Vol. 35, no. 4

310--318

One of the most effective, rapid, and simple methods reversed-phase high-performance liquid chromatography (RP-HPLC) was used for simultaneous development and validation of Eletriptan hydrobromide (ELE HBR) and Itopride hydrochloride (ITP HCL) in combination. The method was validated based on the regulations of United States Pharmacopeia (USP) and International Conference on Harmonization (ICH) guidelines. Separation of both drugs was achieved within approximately 5 min by using a mobile phase made up of a 70:30 ratio of phosphate buffer and acetonitrile having a flow rate of 1 mL min−1. Furthermore, a comprehensive study was conducted on precision, accuracy, linearity, inter-day, intra-day studies, an assay of formulated films, and stability studies of combined prepared film. Co-efficient of correlation ranged between 0.9993, and 0.9965 for ELE HBR and ITP HCL respectively. The accuracy of the developed method was accurate as drug recoveries in both cases of ITP HCL, and ELE HBR falls between (99.87, 99.96, and 99.84%) to (99.81, 99.12, and 98.44%) respectively having a concentration range of solutions between 10, 30 and 50 μg mL−1 dilution. Films developed by using both drugs in combination were then validated for assay studies, and it was found that substantial results of 99.05%, and 99.87% were found in the case of ITP HCL and ELE HBR respectively. The stability of the solution and mobile phase showed the method's accuracy as the results were 97% for ITP HCL and 99% for ELE HBR. The proposed method developed for simultaneous determination of ITP HCL and ELE HBR was developed and validation and no interaction of any excipient were found.

Development and validation of stability-indicating RP-HPLC method for the simultaneous determination of tizanidine HCL and meloxicam in rabbit's plasma

Zaman Muhammad, Hanif Muhammad, Khan Najm Ul Hassan, Mahmood Asif, Qaisar Muhammad Naeem, Ali Huma

Acta Chromatographica

2019

Vol. 31, no. 3

173--178

High-performance liquid chromatography (HPLC) is a widely used technique for the simultaneous detection and quantification of different drugs. The purpose of the current study was to develop a simple and cost-effective reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of tizanidine (TZN) HCl and meloxicam (MLX) in rabbit's plasma. Assay of TZN and MLX was performed after extraction of drug from plasma by liquid–liquid extraction technique using methanol and diethyl ether as protein precipitants. Isocratic elution was performed in a Kromasil® C18 column (dimension, 250 × 4.60 mm; particle size, 5 μm) with mobile phase consisting of methanol–water (8:2). Orthophosphoric acid was used to adjust the pH of the mobile phase 3.0, and detection was done at 228 nm. Flow rate was 0.8 mL/min with ambient temperature and average operating pressure of 1400 psig. Retention time of TZN was 2.612 min and that of MLX was 6.960 min with a resolution of 3.18. Both drugs showed satisfactory linearity in the range of 10 to 50 ng/mL with correlation coefficients (R2) of 0.9989 and 0.9972 for TZN and MLX, respectively. The developed method was validated successfully for linearity, system suitability, intra-day and inter-day accuracy, and precision, robustness, and specificity following International Conference on Harmonization (ICH) guidelines. Conclusively, a precise, stable, reproducible, economical, and suitable method for estimation of pharmacokinetic evaluation was developed and validated.