Author(s)

Sreenivas Pippalla^1*, Venugopal Komreddy², Srinivasulu Kasa³, Vaishnavi Chintala⁴, Poluri Venkata Reddy⁵

¹Department of Chemistry, Sikkim Professional University, Gangtok, India.
²Analytical Research & Development, Hikma Pharmaceuticals USA Inc., Bedford, USA.
³Department of Chemistry, Osmania University, Hyderabad, India.
⁴Analytical Research & Development, Cambrex High Point, High Point, USA.
⁵Department of Analytical Chemistry, Annamalai University, Annamalai Nagar, India.

A rapid, straightforward, sensitive, efficient, and cost-effective reverse-phase high-performance liquid chromatographic method was employed for the simultaneous determination of Sorbitol, Sodium Lactate, and Chlorides in a drug solution for infusion. Sorbitol, Sodium lactate, and Chloride are all officially recognized in the USP monograph. Assay methods are provided through various techniques, with titrations being ineffective for trace-level quantification. Alternatively, IC, AAS, and ICP-MS, though highly accurate, are costly and often unavailable to most testing facilities. When considering methods, it’s important to prioritize both quality control requirements and user-friendly techniques. A simple HPLC simultaneous method was developed for the quantification of Chlorides, Sorbitol, and Sodium Lactate with a shorter run time. The separation utilized a Shimpack SCR-102(H) ion exclusion analytical column (7.9 mm × 300 mm, 7 μm), with a flow rate of 0.6 mL per min. The column compartment temperature was maintained at 40°C, and the injection volume was set at 10 μL, with detection at 200 nm. All measurements were conducted in a 0.1% solution of phosphoric acid. The analytical curves demonstrated linearity (r > 0.9999) in the concentration range of 0.79 to 3.8 mg per mL for Sodium Lactate (SL), 0.16 to 0.79 mg per mL for Sodium Chloride (SC), and 1.5 to 7.2 mg per mL for Sorbitol. Validation of the developed method followed the guidelines of the International Conference on Harmonization (ICH Q2B) and USP<1225>. The method exhibited precision, robustness, accuracy, and selectivity. In accelerated stability testing over 6 months, no significant variations were observed in organoleptic analysis and pH. Consequently, the developed method is deemed suitable for routine quality control analyses, enabling the simultaneous determination of Sodium Lactate, Sodium Chloride, and Sorbitol in pharmaceutical formulations and infusions.

Sorbitol, Sodium Lactate and Chloride, Assay, Analytical Validation, HPLC

Pippalla, S. , Komreddy, V. , Kasa, S. , Chintala, V. and Reddy, P. (2024) Reversed-Phase-HPLC Assay Method for Simultaneous Estimation of Sorbitol, Sodium Lactate, and Sodium Chlorides in Pharmaceutical Formulations and Drug Solution for Infusion. American Journal of Analytical Chemistry, 15, 57-71. doi: 10.4236/ajac.2024.152004.