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Table 6 Stress testing results of pheniramine and naphazoline hydrochloride in stock solution

From: A validated stability-indicating HPLC method for the simultaneous determination of pheniramine maleate and naphazoline hydrochloride in pharmaceutical formulations

Nature of stress Storage conditions Time (h) Amount of pheniramine Amount of naphazoline hydrochloride Extent of decomposition
Remaining ± SD (%) Remaining ± SD (%)
5 M HCl 40°C 24 95.5 ± 0.9(PP = 999.213) 78.5 ± 3.8(PP = 999.412) Substantial
5 M NaOH 40°C 2 65.3 ± 1.4(PP = 999.346) 44.9 ± 2.6(PP = 999.015) Substantial
6% H2O2 40°C 24 84.9 ± 1.6(PP = 999.803) 76.0 ± 1.5(PP = 999.711) Substantial
Thermal 40°C 120 98.2 ± 1.6(PP = 999.872) 102.5 ± 1.0(PP = 999.784) None
40°C 240 99.1 ± 1.3(PP = 999.423) 94.3 ± 1.2(PP = 999.651) Substantial
Dry heat 105°C 7 99.2 ± 2.9(PP = 999.903) 68.4 ± 1.9(PP = 999.806) Substantial
Photolytic 1.2 million lux hours and 200 W h/m2 98.2 ± 1.7(PP = 999.312) 98.5 ± 1.2(PP = 999.104) None
  1. n = Average of 3 determinations.
  2. PP = peak purity factor, peak purity values in the range of 980 ~ 1000 indicate a homogeneous peak.