DEVELOPMENT AND VALIDATION OF A NOVEL RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF SALBUTAMOL SULFATE, GUAIFENESIN, AND AMBROXOL HYDROCHLORIDE IN TABLET FORMULATION

Abstract

A simple and precise liquid chromatography method for the simultaneous estimation of Salbutamol sulfate, Guaifenesin, and Ambroxol hydrochloride in combined tablet dosage form was developed and validated. The chromatographic separation of the drugs was achieved with a Princeton sphere C-8 25 cm × 4.6 mm (Rankem) analytical column using buffer and methanol (58:42 v/v) as the mobile phase. The buffer used in mobile phase contained 0.1 M potassium dihydrogen phosphate and its pH was adjusted to 4.5 with 10% ortho-phosphoric acid. The instrument was set at a flow rate of 1.0 mL min⁻¹, column at ambient temperature, and the wavelength of UV-visible detector at 220 nm. The method showed excellent linearity over a range of 5–35 µg mL⁻¹ for all the drugs. The correlation coefficients for Salbutamol sulfate, Guaifenesin, and Ambroxol hydrochloride were noted to be 0.9998, 0.9998, and 0.9995, respectively, and the mean recovery values were found to be 99.53%, 100.28%, and 100.05%, respectively. The proposed method could be suitable for quantitative determination of these drugs in pharmaceutical preparations and also for quality control in bulk manufacturing. The intermediate precision data was subjected to statistical analysis (F-test and t-test at 95% confidence level).

Keywords:

• ambroxol hydrochloride
• guaifenesin
• RP-HPLC
• salbutamol sulfate
• simultaneous estimation

ACKNOWLEDGMENT

The authors are grateful to Sun Pharmaceutical (Mumbai, India) for providing gift samples of SS, GF, and AH. The authors are also thankful to Ms. Deepika Jain, Assistant Professor, School of Pharmaceutical Sciences, Shobhit University for her support.

Notes

Values are reported as mean ±s.d. of three calibration curves generated on three consecutive days (n = 3). Seven concentrations in the linearity range were evenly distributed.

^a The values in parenthesis are the theoretical values of f-test and student's t test at 95% confidence level.

^a The values in parenthesis are the theoretical values of f-test and student's t test at 95% confidence level.

*Chromatographic conditions: mobile phase; phosphate buffer (0.1 m potassium dihydrogen phosphate, ph adjusted 4.5 with 10% ortho-phosphoric acid) and methanol (58:42 v/v) maintained with flow rate of 1.0 mL/min-1, and detector wavelength of 220 nm using a UV-visible detector.